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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02241616 |
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Date of registration:
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12/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Traditional Chinese Medicine Combined With Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV
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Scientific title:
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A Multi-Center Study to Assess the Efficacy and Safety of Traditional Chinese Medicine Combined With Entecavir for Patients With Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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350 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02241616 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Zhimin Zhao, PhD |
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Address:
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Telephone:
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+8615800581663 |
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Email:
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kilorair@sina.com |
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Affiliation:
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Name:
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Chenghai Liu, PhD |
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Address:
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Telephone:
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8621-20256521 |
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Email:
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chenghailiu@hotmail.com |
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Affiliation:
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Name:
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Chenghai Liu, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ShuGuang Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hepatitis B history or more than 6 months history of positive HBsAg
- Within 2 years of Entecavir treatment, HBV-DNA is negative but has not reach the
clinical endpoint (HBeAg seroconversion or HBsAg loss in HBeAg-positive patients;
HBsAg loss or anti-HBs seroconversion in HBeAg-negative patients)
- Age 18-60
- Ishak fibrosis score of the biopsy within 6 months =5, no anti-fibrosis drug was taken
within 6 months.
- Child-Pugh<7 (Stage A)
- The patient or the patient's guardian agrees to participate the random controlled
trial and sign the Informed Consent Form.
Exclusion Criteria:
- Decompensated liver cirrhosis
- HCC
- Liver histology conforming to other chronic liver diseases, such as moderate or severe
non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic
hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis,
primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic
induced liver injury, parasitic infections, alcoholic liver disease.
- Have psychiatric history or uncontrollable epilepsy patient.
- Uncontrollable diabetic patient
- History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle cell
disease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.
- Severe background disease like chronic respiratory failure, circulatory failure,
kidney failure etc.
- In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrow
transplantation and stem cell transplantation.
- Immunocompromised patients: such as HIV infection or take immunosuppressor or
Glucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3
months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancer
chemotherapy) and radioactive therapy.
- Gestation or lactation period women and women who plan to get pregnant during the
study period.
- Patient who are allergy to the experimental drug.
- Using history of other anti-viral drug within 6 months.
- Patients who are participating other trials.
- Other situation where PI thinks the patient should be excluded.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis B Virus Related Cirrhosis
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Intervention(s)
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Drug: Entecavir+Fuzheng Huayu+TCM Granule
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Primary Outcome(s)
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Degree of liver fibrosis
[Time Frame: 48 weeks]
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Secondary ID(s)
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SGHLC20140818002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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