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CompletedNCT04614779Updated Nov 22, 2023

Long-term Clinical Study of CN128 in Thalassemia Patients

A Phase 2 interventional study of CN128 Tablets in Thalassemia and Iron Overload, sponsored by Hangzhou Zede Pharma-Tech Co., Ltd.. Completed at 1 site in China. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Hangzhou Zede Pharma-Tech Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
16 Years to 60 Years
Sex
All
01

Study summary

  1. Primary objectives:

    • To evaluate the safety and efficacy of long-term orally administration of CN128 in thalassaemia patients with blood transfusion dependent and aged 16 and above.

  2. Design:

    • The study is designed as a single arm and opened phase IIa clinical trial, so as to investigate the safety and efficacy of CN128.
    • A total of 50 eligible subjects are planned to be enrolled, and orally administration of CN128 for 24 weeks or 48 weeks according to the administration plan. The treatment period is from day 0 to 24 weeks, and the extended treatment period was from 25 weeks to 96 weeks.
    • Subjects' medication status, uncomfortable symptoms, concomitant medication or non-drug therapy were recorded daily.

  3. Subject inclusion criteria:

    • Thalassemia patients.
    • The number of blood transfusion per month ≥1. Or hemoglobin can not be maintained at 90g/L above, if blood transfusions is less than once per month.
    • Serum ferritin ≥ 500 µg/L
    • Patients aged 16 and above
    • Volunteer for the trial and sign the informed consent.

  4. Subject exclusion criteria:

    • Active hepatitis B (HBsAg positive, HBsAb negative) or hepatitis C (HCV antibody positive, detectable HCV RNA, and alanine transaminase (ALT) beyond normal range)
    • Active gastrointestinal disease history (including: gastric ulcer, duodenal ulcer, stomach or esophageal varices, ulcerative colitis, Crohn's disease, gastrointestinal cancer, familial genetic multiple intestinal polyps), and History of gastrointestinal perforation, gastrointestinal surgery that influence drug absorption, and other potential intestinal complications considered by researchers;
    • ALT or Aspartate transaminase (AST) > 2.5 × Upper limit of normal (ULN), or serum creatinine > 1.5 × ULN;
    • Neutropenia patient (neutrophil count \< 1.5 × 109 / L);
    • Active infection uncontrolled;
    • The patients who are currently taking CYP3A strong inducer or strong inhibitor drugs, or the drug that may extend the QT interval, or the drug that may decrease neutrophil count, but can not temporarily interrupt the use of such drugs;
    • Congenital long QT syndrome or known family history of long QT syndrome; QTc > 480 ms; clinically significant ventricular or atrial fast arrhythmia;
    • The patients who can not accept MRI as detection means, such as claustrophobic for MRI, pacemaker, and those using ferromagnetic metal implants.
    • Birth planner (including male subjects) within or within 3 months after the end of the trial;
    • Participated in other clinical trials in the three months before taking the test preparation, except for non-interventional studies;
    • Pregnant or lactating women;
    • Unsuitable to participate in the trial considered by the researchers.

  5. Usage:

    • All subjects will be given the lower (10 mg/kg bw, bid) or higher dose (15 mg/kg bw, bid) for 24 or 48 weeks, according to the administration plan.
    • All subjects will be given the lower (15 mg/kg bw, bid) or higher dose (20 mg/kg bw, bid) for 49 or 96 weeks, according to the administration plan.

  6. Safety assessments:

    Safety evaluations include adverse events, adverse reactions, severe adverse events, and severe adverse reactions; growth (weight, height); total and free testosterone in men, follicle-generating hormone and luteinizing hormone in women; vital signs and electrocardiogram; hearing, laboratory tests (blood routine analytes, blood biochemistry, coagulation function, thyroid and para-thyroid function, urine routine analytes.), urine pregnancy test (women of childbearing age),Levels of drug exposure during the study.

  7. Efficacy assessments:

    Efficacy evaluations include serum ferritin, liver iron content (MRI R2) and cardiac iron content (MRI T2*).

  8. Statistics:

    • Subject characteristic distribution Demographic characteristics, general conditions, and baseline conditions (pre-treatment) of enrolled subjects were analyzed.The measurement data are described by means, standard deviation, minimum value and maximum value, while the qualitative data list frequency and percentage.
    • Safety analysis Descriptive statistical analysis was used for safety endpoints.
    • Effectiveness analysis Mean, standard deviation, median, minimum and maximum values were described and 95% confidence intervals were calculated. Paired T-test was used to compare each time point with the baseline if necessary. The 95% confidence interval was calculated by using Clopper-Pearson method for the proportion of patients.
Read the detailed description

Clinical Trial - IIa - Study Description - Detailed Description

  1. Primary objectives:

    • To evaluate the adverse events, adverse reactions, severe adverse events and severe adverse reactions during the study period, so as to investigate the safety;
    • To evaluate the changes of serum ferritin over time after orally administration of CN128 in thalassaemia patients with blood transfusion dependent and aged 16 and above, so as to investigate the efficacy;
    • To evaluate the effect on iron excretion in liver after orally administration of CN128 for 12, 24 weeks in thalassaemia patients with blood transfusion dependent and aged 16 and above, so as to investigate the efficacy;
    • To evaluate the effect on iron excretion in heart after orally administration of CN128 for 12, 24 weeks in thalassaemia patients with blood transfusion dependent and aged 16 and above, so as to investigate the efficacy;
    • To evaluate the proportion of patients with decreased or unchanged liver iron content after orally administration of CN128 for 12, 24 weeks in thalassaemia patients with blood transfusion dependent and aged 16 and above, so as to investigate the efficacy;
    • To evaluate the safety and efficacy of long-term orally administration of CN128 in thalassaemia patients with blood transfusion dependent and aged 16 and above.

  2. Design:

    • The study is designed as a single arm and opened phase IIa clinical trial, so as to investigate the safety and efficacy of CN128.
    • A total of 50 eligible subjects are planned to be enrolled, and orally administration of CN128 for 24 weeks or 48 weeks according to the administration plan. The treatment period is from day 0 to 24 weeks, and the extended treatment period was from 25 weeks to 96 weeks.
    • Administration plan:

    (1)0 day\~48 weeks： The trial will start with the lower dose of CN128 (10 mg/kg body weight [bw], bid) for two weeks, then the subjects will return to the study center. If no unacceptable toxicity associated with CN128 is found, the subjects will be given the higher dose (15 mg/kg body weight [bw], bid). If unacceptable toxicity associated with CN128 is found, the subjects will be suspended or stopped administration. If the adverse event turns to normal or abnormal but no clinical significance after suspension administration, the subjects will be given the lower dose of CN128 (10 mg/kg body weight [bw], bid).

    After taking CN128 at 15 mg/kg, if unacceptable toxicity associated with CN128 is found, the dosage will be reduce to 10 mg/kg. If no symptoms appear, the dose can be increased to 15 mg/kg. If the unacceptable toxicity related to CN128 still occurs, the subjects will be suspended or stopped administration. If the adverse event turns to normal or abnormal but no clinical significance after suspension administration, the subjects will be given the lower dose of CN128 (10 mg/kg body weight [bw], bid). The dose will be assessed once every two or four weeks.

    Subjects' medication status, uncomfortable symptoms, concomitant medication or non-drug therapy were recorded daily.

    (2)49 weeks\~96 weeks： Subjects who have completed 48 weeks of treatment may continue dosing at the original dose until the end of the study or withdraw early if they do not experience intolerable toxicity associated with CN128 tablets and have fair efficacy (≥20% elevation on MRI T2*) and if, in the judgment of the investigator, the benefits outweigh the risks.

    Subjects who have completed 48 weeks of treatment, who have not experienced intolerable toxicity associated with CN128 tablets, but who have been assessed by the investigator as having poor efficacy (\<20% elevation of MRI T2*) and in the judgment of the investigator the benefit outweighs the risk, may, with the subject's consent, have the dosage increased at the additional visit or the established most recent visit to 15 mg/kg in the morning and 20 mg/kg in the evening, with an assessment made at 2 weeks of dosing：

    If no relevant intolerable toxicity occurs, the dose may continue to be increased to 20 mg/kg bid and assessed after 2 weeks of dosing:

    1. If no relevant intolerable toxicity occurs, the 20 mg/kg bid dose may be administered until the end of the study or early withdrawal (daily dose 40 mg/kg/d);
    2. If relevant intolerable toxicity occurs, the dose may be reduced to 15 mg/kg in the morning and 20 mg/kg bid in the evening until the end of the study or early withdrawal (daily dose 35 mg/kg/d).

    If relevant intolerable toxicity occurs, the dose may be reduced to 15 mg/kg bid until the end of the study or early withdrawal (daily dose 30 mg/kg/d).

  3. Subject inclusion criteria:

    • Thalassemia patients.
    • The number of blood transfusion per month ≥1. Or hemoglobin can not be maintained at 90g/L above, if blood transfusions is less than once per month.
    • Serum ferritin ≥ 500 µg/L
    • Patients aged 16 and above
    • Volunteer for the trial and sign the informed consent.

  4. Subject exclusion criteria:

    • Active hepatitis B (HBsAg positive, HBsAb negative) or hepatitis C (HCV antibody positive, detectable HCV RNA, and ALT beyond normal range)
    • Active gastrointestinal disease history (including: gastric ulcer, duodenal ulcer, stomach or esophageal varices, ulcerative colitis, Crohn's disease, gastrointestinal cancer, familial genetic multiple intestinal polyps), and History of gastrointestinal perforation, gastrointestinal surgery that influence drug absorption, and other potential intestinal complications considered by researchers;
    • ALT or AST > 2.5 × ULN, or serum creatinine > 1.5 × ULN;
    • Neutropenia patient (neutrophil count \< 1.5 × 109 / L);
    • Active infection uncontrolled;
    • The patients who are currently taking CYP3A strong inducer or strong inhibitor drugs, or the drug that may extend the QT interval, or the drug that may decrease neutrophil count, but can not temporarily interrupt the use of such drugs;
    • The patients who are allergic or contraindicated to the main ingredients or excipients of CN128 tablets;
    • Congenital long QT syndrome or known family history of long QT syndrome; QTc > 480 ms; clinically significant ventricular or atrial fast arrhythmia;
    • The patients who can not accept MRI as detection means, such as claustrophobic for MRI, pacemaker, and those using ferromagnetic metal implants;
    • Birth planner (including male subjects) within or within 3 months after the end of the trial;
    • Participated in other clinical trials in the three months before taking the test preparation, except for non-interventional studies;
    • Pregnant or lactating women;
    • Unsuitable to participate in the trial considered by the researchers.

  5. Usage:

    All subjects will be given the lower (10 mg/kg bw, bid) or higher dose (15 mg/kg bw, bid) for 24 or 48 weeks, according to the administration plan.

    All subjects will be given the lower (15 mg/kg bw, bid) or higher dose (20 mg/kg bw, bid) for 49 or 96 weeks, according to the administration plan.

  6. Safety assessments:

    Safety evaluations include adverse events, adverse reactions, severe adverse events, and severe adverse reactions; growth (weight, height); total and free testosterone in men, follicle-generating hormone and luteinizing hormone in women; vital signs and electrocardiogram; hearing, laboratory tests (blood routine analytes, blood biochemistry, coagulation function, thyroid and para-thyroid function, urine routine analytes.), urine pregnancy test (women of childbearing age),Levels of drug exposure during the study.

  7. Efficacy assessments:

    Efficacy evaluations include serum ferritin, liver iron content (MRI R2) and cardiac iron content (MRI T2*).

  8. Statistics:

    • Subject characteristic distribution Demographic characteristics, general conditions, and baseline conditions (pre-treatment) of enrolled subjects were analyzed.The measurement data are described by means, standard deviation, minimum value and maximum value, while the qualitative data list frequency and percentage.
    • Safety analysis Descriptive statistical analysis was used for safety endpoints. Summarize the incidence of adverse events, adverse reactions, adverse events leading to withdrawal from the trial, adverse events leading to death, severe adverse events, and severe adverse reactions. The incidence is calculated by subsystem, symptom/sign. Severity of adverse events and adverse reactions: if multiple adverse events occur in the same subject, the most serious one is included in the analysis; if different adverse events occurred in the same subject, the most severe adverse events were counted in the analysis. Drug exposure during the study: describe medication compliance during the study, actual dose, administration adjustments during the study, whether the study was discontinued, and reasons for the suspension.
    • Effectiveness analysis Mean, standard deviation, median, minimum and maximum values were described and 95% confidence intervals were calculated. Paired T-test was used to compare each time point with the baseline if necessary. The 95% confidence interval was calculated by using Clopper-Pearson method for the proportion of patients.
02

Conditions studied

  • Thalassemia
  • Iron Overload
03

In context

Thalassemia

250 studies on the registry are indexed under Thalassemia; 43 are open to participants now.

This study's enrollment of 18 is below the median of 33 across 170 interventional studies indexed under Thalassemia.

Browse Thalassemia studies →

Lead sponsor

Hangzhou Zede Pharma-Tech Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Thalassemia patients.
  • The number of blood transfusion per month ≥1. Or can not be maintained at 90g/L above, if blood transfusions is less than once per month.
  • Serum ferritin ≥ 500 µg/L
  • Patients aged 16 and above
  • Volunteer for the trial and sign the .

Exclusion criteria

Exclusion Criteria:

  • Active (HBsAg positive, HBsAb negative) or (HCV antibody positive, detectable HCV RNA, and beyond normal range)
  • Active gastrointestinal disease history (including: gastric ulcer, duodenal ulcer, stomach or esophageal varices, ulcerative colitis, Crohn's disease, gastrointestinal cancer, familial genetic multiple intestinal polyps), and History of gastrointestinal perforation, gastrointestinal surgery that influence drug absorption, and other potential intestinal complications considered by researchers;
  • ALT or AST > 2.5 × , or serum creatinine > 1.5 × ULN;
  • Neutropenia patient ( \< 1.5 × 109 / L);
  • Active infection uncontrolled;
  • The patients who are currently taking strong inducer or strong inhibitor drugs, or the drug that may extend the , or the drug that may decrease neutrophil count, but can not temporarily interrupt the use of such drugs;
  • The patients who are allergic or to the main ingredients or of CN128 tablets;
  • Congenital long QT syndrome or known family history of long QT syndrome; QTc > 480 ms; ventricular or atrial fast arrhythmia;
  • The patients who can not accept MRI as detection means, such as claustrophobic for MRI, pacemaker, and those using ferromagnetic metal implants;
  • Birth planner (including male subjects) within or within 3 months after the end of the trial;
  • Participated in other clinical trials in the three months before taking the test preparation, except for non-interventional studies;
  • Pregnant or lactating women;
  • Unsuitable to participate in the trial considered by the researchers.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    CN128 Group

    All subjects will be given the lower (10 mg/kg bw, bid) or higher dose (15 mg/kg bw, bid) for 24 or 48 weeks, according to the administration plan. All subjects will be given the lower (15 mg/kg bw, bid) or higher dose (20 mg/kg bw, bid) for 49 or 96 weeks, according to the administration plan. The dosage form is tablets.

    Drug: CN128 Tablets

Interventions

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events, adverse reactions, severe adverse events and severe adverse reactions as a measure of safety and tolerability during the study period

    To determine the incidence, type and severity of adverse events, adverse reactions, severe adverse events and severe adverse reactions in patients up to 96 weeks.

    Time frame: up to 96 weeks

  2. Absolute Change in Weight (Unit: kg) From Baseline Over Time

    The patient's weight will be determined, and it's one kind of Physical examination.

    Time frame: Baseline, 24, 48, 72 and 96 weeks.

  3. Absolute Change in Height (Unit: m) From Baseline Over Time

    The patient's height will be determined, and it's one kind of Physical examination.

    Time frame: Baseline,24, 48, 72 and 96 weeks.

  4. Absolute Change in Hormon (total and free testosterone in men, follicle-generating hormone and luteinizing hormon in women) From Baseline Over Time

    Hormon will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 24, 48, 72 and 96 weeks.

  5. Absolute Change in Temperature (Unit: ℃）From Baseline Over Time

    The patient's temperature will be determined, and it's one kind of vital signs checks.

    Time frame: Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  6. Absolute Change in Blood pressure (Unit: mmHg ) From Baseline Over Time

    Both patient's systolic and diastolic blood pressure will be measured, and it's one kind of vital signs checks.

    Time frame: Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  7. Absolute Change in Heart rate (Unit: bpm) From Baseline Over Time

    The patient's heart rate will be determined, and it's one kind of vital signs checks.

    Time frame: Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  8. Absolute Change in Respiration (Unit: bpm) From Baseline Over Time

    The patient's respiration will be determined, and it's one kind of vital signs checks.

    Time frame: Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  9. Absolute Change in Electrocardiogram (P-R (Unit: ms), QRS (Unit: ms), QTc (Unit: ms), etc) From Baseline Over Time

    The patient's electrocardiogram will be measured, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  10. Change in Auditory Function From Baseline Over Time

    The patient's auditory function will be determined by otorhinolaryngology.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  11. Absolute Change in White Blood Count (Unit: 10E9/L) From Baseline Over Time

    The patient's white blood count will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  12. Absolute Change in Neutrophil Count (Unit: 10E9/L) From Baseline Over Time

    The patient's neutrophil count will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  13. Absolute Change in Lymphocyte Count (Unit: 10E9/L) From Baseline Over Time

    The patient's lymphocyte count will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  14. Absolute Change in Monocyte Count (Unit: 10E9/L) From Baseline Over Time

    The patient's monocyte count will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  15. Absolute Change in Eosinophilic Count (Unit: 10E9/L) From Baseline Over Time

    The patient's eosinophilic count will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  16. Absolute Change in Basophilic Count (Unit: 10E9/L) From Baseline Over Time

    The patient's basophilic count will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  17. Absolute Change in Red Blood Count (Unit: 10E9/L) From Baseline Over Time

    The patient's red blood count will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  18. Absolute Change in Hemoglobin (Unit: g/L) From Baseline Over Time

    The patient's hemoglobin will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  19. Absolute Change in Hematocrit (Unit:%) From Baseline Over Time

    The patient's hematocrit will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  20. Absolute Change in Blood Platelet Count (Unit: 10E9/L) From Baseline Over Time

    The patient's blood platelet count will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  21. Absolute Change in Thrombocytocrit (Unit: %) From Baseline Over Time

    The patient's thrombocytocrit will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  22. Absolute Change in Alanine Aminotransferase (Unit: U/L) From Baseline Over Time

    The patient's alanine aminotransferase will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  23. Absolute Change in Total Bilirubin (Unit:µmol/L) From Baseline Over Time

    The patient's total bilirubin will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  24. Absolute Change in Total Protein (Unit:g/L) From Baseline Over Time

    The patient's total protein will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  25. Absolute Change in Albumin (Unit: g/L) From Baseline Over Time

    The patient's albumin will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  26. Absolute Change in Globulin (Unit: g/L) From Baseline Over Time

    The patient's globulin will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  27. Absolute Change in Alkaline Phosphatase (Unit: U/L) From Baseline Over Time

    The patient's alkaline phosphatase will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  28. Absolute Change in Lactate Dehydrogenase (Unit: IU/L) From Baseline Over Time

    The patient's lactate dehydrogenase will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  29. Absolute Change in Urea (Unit: mmol/L) From Baseline Over Time

    The patient's urea will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  30. Absolute Change in Creatinine (Unit:µmol/L) From Baseline Over Time

    The patient's creatinine will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  31. Absolute Change in Glucose (Unit: mmol/L) From Baseline Over Time

    The patient's glucose will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  32. Absolute Change in Potassium (Unit: mmol/L) From Baseline Over Time

    The patient's potassium will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  33. Absolute Change in Sodium (Unit: mmol/L) From Baseline Over Time

    The patient's sodium will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  34. Absolute Change in Chlorine (Unit: mmol/L) From Baseline Over Time

    The patient's chlorine will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  35. Absolute Change in Calcium (Unit: mmol/L) From Baseline Over Time

    The patient's calcium will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  36. Absolute Change in Aspartate Aminotransferase (Unit: U/L) From Baseline Over Time

    The patient's aspartate aminotransferase will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  37. Absolute Change in Fibrinogen (Unit: g/L) From Baseline Over Time

    The patient's fibrinogen will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  38. Absolute Change in Prothrombin time (Unit: s) From Baseline Over Time

    The patient's prothrombin time will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  39. Absolute Change in Activated Partial Thromboplastin Time (APTT, Unit: s) From Baseline Over Time

    The patient's APTT will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  40. Absolute Change in Thyroid and para-gland function (Serum total thyroxine, parathyroid hormone, total triiodothyronine and thyrotropin) From Baseline Over Time

    The patient's thyroid and para-gland function will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  41. Absolute Change in Urine Glucose (Unit: mmol/L) From Baseline Over Time

    The patient's urine glucose will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  42. Absolute Change in Urine Protein (Unit: g/L)) From Baseline Over Time

    The patient's urine protein will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  43. Absolute Change in Dosage（mg/kg）during the study period

    The dosages will be investigated up to 96 weeks.

    Time frame: Up to 96 weeks

  44. Duration of Administration during the study period

    The duration of administration will be investigated up to 96 weeks.

    Time frame: Up to 96 weeks

  45. Number of Participants during the study period

    The number of participants will be investigated up to 96 weeks.

    Time frame: Up to 96 weeks

  46. Absolute Change in Serum ferritin (Unit: µg/L) From Baseline Over Time

    Serum ferritin will be determined, and it's one kind of laboratory test.

    Time frame: Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks.

  47. Absolute Change in Liver iron content (MRI R2) From Baseline Over Time

    Liver iron content will be determined by liver magnetic resonance.

    Time frame: Baseline, 12, 24, 48, 72 and 96 weeks.

  48. Absolute Change in Heart iron content (MRI T2*) From Baseline Over Time

    Heart iron content will be determined by cardio magnetic resonance.

    Time frame: Baseline, 12, 24, 48, 72 and 96 weeks.

07

Study locations

1 site
  • The First Affiliated Hospital Of Guangxi Medical University
    Nanning, Guangxi 530021, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Aug 2022, 22 months.

Of 25 phase 2 interventional studies under Thalassemia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 67. This study's 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2020
First posted
Nov 4, 2020
StartActual
Sep 30, 2020
Primary completionActual
Aug 18, 2022
CompletionActual
Aug 18, 2022
Last update
Nov 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04614779
Lead sponsor
Hangzhou Zede Pharma-Tech Co., Ltd.
Responsible party
Sponsor
First posted
Nov 4, 2020
Start date
Sep 30, 2020
Primary completion
Aug 18, 2022
Completion
Aug 18, 2022
Last update
Nov 22, 2023

Study contacts

Jianmin Jianmin, PhD
principal investigator · First Affiliated Hospital of Guangxi Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: CN128

Other studies in this condition

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Hangzhou Zede Pharma-Tech Co., Ltd.

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