A Phase 4 interventional study of Babaodan Capsule in Primary Biliary Cholangitis, sponsored by Mei Han. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Mei Han · Phase 4, Interventional, and Treatment
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(1) Other indicators of liver function: ALP, GGT, AST, ALT, TBA, TBil, DBil, IBil; (2) Itching and fatigue symptom scores; (3) Biochemical response rate; (4) Histologic changes; (5) Changes in immunologic indices (serum IgM, IgG, IgA, autoantibodies AMA/AMA-M2 and anti-gp210 antibody, anti-sp100 antibody); (6) Adverse events and safety evaluation.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 151 interventional studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Mei Han is the lead sponsor of 4 studies on the registry; 3 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 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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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 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.
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.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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 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.
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.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Babaodan Capsule (State Drug License: Z10940006) is manufactured by Xiamen Traditional Chinese Medicine Factory Co., Ltd; Packing specification: 0.3g/capsule, 6 capsules/board×2 boards/carton; Ingredients are in vitro cultivated cowhide, snake gallbladder, antelope horn, pearl, panax ginseng, artificial musk and so on.
Drug: Babaodan Capsule
Babao Dan Capsule (State Drug License: Z10940006) is produced by Xiamen Traditional Chinese Medicine Factory Co., Ltd; Packing specification: 0.3g/capsule, 6 capsules/board×2 boards/small box; Ingredients are in vitro cultivated cowhide, snake gallbladder, antelope horn, pearl, panax ginseng, artificial musk, and so on. Intervention measures are really the original UDCA treatment program based on the addition of eight treasure Dan capsule, 2 capsules / times, tid, oral. Course of treatment: 3 months (based on 30 days/month).
Total bilirubin (TBil) reversion rate
Total bilirubin (TBil) reversion rate: cases with normal total bilirubin index after treatment/60 cases × 100%
Time frame: 90 days
Total bilirubin (TBil) efficacy rate
Total bilirubin (TBil) efficacy rate: total bilirubin index decreased by 1×ULN cases/60 cases×100% after treatment compared with before treatment.
Time frame: 90 days
biological response rate
Biological response rate of UDCA combined with Baobao Dan capsule in the treatment of PBC: number of cases meeting the biochemical response standard criteria / 60 cases × 100%. Referring to the UDCA treatment of PBC proposed in the "Diagnostic and therapeutic standard of primary biliary cholangitis (2021)", ALP \<1.67×ULN was used as the biochemical response standard.
Time frame: 90 days
ALT
The actual level of ALT was collected in the form of measured information.
Time frame: 90 days
AST
The actual level of AST was collected in the form of measured information.
Time frame: 90 days
ALP
The actual level of ALP was collected in the form of measured information.
Time frame: 90 days
TBA
The actual level of TBA was collected in the form of measured information.
Time frame: 90 days
DBil
The actual level of DBil was collected in the form of measured information.
Time frame: baseline, 30 days, 60 days, 90 days
IBil
The actual level of IBil was collected in the form of measured information.
Time frame: 90 days
5-D Pruritus Scale Score
Evaluation was performed according to the 5-D Pruritus Scale Score, which includes 5 aspects of site, duration, intensity, tendency, and impairment of life, with a total score of 5 to 25.
Time frame: 90 days
Fatigue section of the PBC-40 questionnaire
It was carried out using the entries of malaise in the Quality of Life Questionnaire for Patients with Primary Biliary Cholangitis (PBC-40), which consisted of 11 items that were categorized according to the degree of malaise as none, seldom, sometimes, often, and continually, with scores of 1, 2, 3, 4, and 5, respectively, and a total score of 11-55.
Time frame: 90 days
Immunological indicators - serum IgM
The actual level of serum IgM was collected in the form of measured information.
Time frame: 90 days
Immunological indicators - serum IgG
The actual level of serum IgG was collected in the form of measured information.
Time frame: 90 days
Immunological indicators - serum IgA
The actual level of serum IgA was collected in the form of measured information.
Time frame: 90 days
Immunological indicators - anti-gp210 antibody
The actual level of anti-gp210 antibody was collected in the form of measured information.
Time frame: 90 days
Immunological indicators - anti-sp100 antibody
The actual level of anti-sp100 antibody was collected in the form of measured information.
Time frame: 90 days
Immunological indicators - autoantibodies AMA/AMA-M2
The actual level of autoantibodies AMA/AMA-M2 was collected in the form of measured information.
Time frame: 90 days
Histopathology of the liver - grading of inflammatory activity
Baseline liver puncture biopsy results were valid for 6 months prior to screening, allowing patients to refuse to provide a histologic sample of the liver. The grading of inflammatory activity was observed and changes in the frequency of each corresponding grade were analyzed.
Time frame: Changes of 90 days from the baseline.
Histopathology of the liver - staging of the degree of fibrosis
Baseline results of hepatic puncture biopsy were valid for 6 months prior to screening, allowing patients to refuse to provide a histologic sample of the liver. The staging of the degree of fibrosis was observed and changes in the frequency of each corresponding grade were analyzed.
Time frame: Changes of 90 days from the baseline.
12-lead electrocardiogram
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal 12-lead electrocardiogram.
Time frame: baseline, 30 days, 60 days, 90 days
Physical examination
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal physical examination which concludes general examination of the whole body, head examination, neck examination, chest examination, abdominal examination, etc.
Time frame: baseline, 30 days, 60 days, 90 days
Routine blood test
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal routine blood test which concludes RBC, Hb, HCT, MCV, MCHC, RDW, WBC, Neut, Lymph, Mono, Eos, Basso, PLT.
Time frame: baseline, 30 days, 60 days, 90 days
Renal Function Tests-BUN
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal BUN.
Time frame: baseline, 30 days, 60 days, 90 days
Renal Function Tests-UA
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal UA.
Time frame: baseline, 30 days, 60 days, 90 days
Renal Function Tests-Scr
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal Scr.
Time frame: baseline, 30 days, 60 days, 90 days
Urinalysis
This is a safety outcome.
Time frame: baseline, 30 days, 60 days, 90 days
Coagulation tests-PT
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal PT.
Time frame: baseline, 30 days, 60 days, 90 days
Coagulation tests-APTT
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal APTT.
Time frame: baseline, 30 days, 60 days, 90 days
Coagulation tests-TT
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal TT.
Time frame: baseline, 30 days, 60 days, 90 days
Coagulation tests-FIB
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal FIB.
Time frame: baseline, 30 days, 60 days, 90 days
Urine beta-hCG pregnancy test
This is a safety outcome.
Time frame: baseline, 30 days, 60 days, 90 days
adverse event
This is a safety outcome.
Time frame: baseline, 30 days, 60 days, 90 days, 100 days
Body temperature
This is a safety outcome.
Time frame: baseline, 30 days, 60 days, 90 days
Heart rate
This is a safety outcome.
Time frame: baseline, 30 days, 60 days, 90 days
Number of breaths in 1 min
This is a safety outcome.
Time frame: baseline, 30 days, 60 days, 90 days
Blood pressure-Diastolic blood pressure(mmHg)
This is a safety outcome.
Time frame: baseline, 30 days, 60 days, 90 days
Blood pressure-Systolic blood pressure(mmHg)
This is a safety outcome.
Time frame: baseline, 30 days, 60 days, 90 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2024; primary completion for Jul 2025, 15 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Babao dan
Mei Han