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 2025-03-14.
Sponsored by Hangzhou Zede Pharma-Tech Co., Ltd. · Phase 2, Interventional, and Treatment
The safety and efficacy of CN128 is studied in thalassaemia with sever liver iron overloaded patients.
The trial will start with the lower dose of CN128 (10 mg/kg body weight [bw], bid) for one week. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 15 mg/kg body weight [bw], bid for one week. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 20 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 25 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 30 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 30 mg/kg body weight [bw], bid to Week 52. Dosage will be adjusted according to subject status and study plan.
250 studies on the registry are indexed under Thalassemia; 43 are open to participants now.
This study's enrollment of 16 is below the median of 33 across 170 interventional studies indexed under Thalassemia.
Browse Thalassemia studies →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.
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.
Exclusion Criteria:
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.
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).
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 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 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.
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.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will be given the lower (10 mg/kg bw, bid) to higher dose (30 mg/kg bw, bid) for 52 weeks, according to the administration plan. The dosage form is tablets.
Drug: CN128 Tablets
Iron chelator, oral tablets
Also known as: CN128
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 52 weeks.
Time frame: Up to 52 weeks
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
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, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
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, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
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, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Electrocardiogram (P-R (Unit: ms), QRS (Unit: ms), QTc interval (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, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Change in Auditory Function From Baseline Over Time
The patient's auditory function will be determined by otorhinolaryngology.
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in White Blood Count (Unit: 10^9/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, 26, 39 and 52 weeks.
Absolute Change in Neutrophil Count (Unit: 10^9/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, 26, 39 and 52 weeks.
Absolute Change in Lymphocyte Count (Unit: 10^9/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, 26, 39 and 52 weeks.
Absolute Change in Monocyte Count (Unit: 10^9/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, 26, 39 and 52 weeks.
Absolute Change in Eosinophilic Count (Unit: 10^9/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, 26, 39 and 52 weeks.
Absolute Change in Basophilic Count (Unit: 10^9/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, 26, 39 and 52 weeks.
Absolute Change in Red Blood Count (Unit: 10^9/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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
Absolute Change in Blood Platelet Count (Unit: 10^9/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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
Absolute Change in Glucose (Unit: mmol/L) From Baseline Over Time [ Time
The patient's glucose will be determined, and it's one kind of laboratory test.
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
Absolute Change in Serum Total Thyroxine (Unit: nmol/L) From Baseline Over Time
The patient's serum total thyroxine will be determined, and it's one kind of laboratory test.
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Parathyroid Hormone (Unit: pg/mL) From Baseline Over Time
The patient's parathyroid hormone will be determined, and it's one kind of laboratory test.
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Triiodothyronine (Unit: nmol/L) From Baseline Over Time
The patient's total triiodothyronine will be determined, and it's one kind of laboratory test.
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Thyrotropin (Unit: mIU/L) From Baseline Over Time
The patient's thyrotropin will be determined, and it's one kind of laboratory test.
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
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, 26, 39 and 52 weeks.
Absolute Change in Total Testosterone (Unit: ng/ml) in men From Baseline Over Time
The patient's total testosterone will be determined in men, and it's one kind of laboratory test.
Time frame: Baseline, 26, 39 and 52 weeks.
Absolute Change in Free Testosterone (Unit: nmol/L) in men From Baseline Over Time
The patient's free testosterone will be determined in men, and it's one kind of laboratory test.
Time frame: Baseline, 26, 39 and 52 weeks.
Absolute Change in Follicle-generating Hormone (Unit: mIU/mL) in women From Baseline Over Time
The patient's follicle-generating hormone will be determined in women, and it's one kind of laboratory test.
Time frame: Baseline, 26, 39 and 52 weeks.
Absolute Change in Luteinizing Hormon (Unit: mIU/mL) in women From Baseline Over Time
The patient's luteinizing hormonwill be determined in women, and it's one kind of laboratory test.
Time frame: Baseline, 26, 39 and 52 weeks.
Absolute Change in Liver iron content (Unit: mg/g dw) From Baseline Over Time
Liver iron content will be determined by liver magnetic resonance.
Time frame: Baseline, 12, 26,39 and 52 weeks.
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, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CN128
Hangzhou Zede Pharma-Tech Co., Ltd.