Treatment of Liver Cirrhosis Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir

Phase 4

• Conditions: Liver Cirrhosis Due to Hepatitis B Virus
• Interventions: Drug: Entecavir + Placebo; Drug: Entecavir + Fuzheng Huayu Tablet

• Registration Number: NCT02241590
• Lead Sponsor: ShuGuang Hospital

Brief Summary

Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix is still required and hopefully improve the efficacy of anti-virals for liver fibrotic patients with HBV, especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve the reversion of liver cirrhosis due to HBV.

The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients with liver cirrhosis due to HBV.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• More than 6 months history of serum positive HBsAg
• Positive HBV-DNA
• Age 18-60
• Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-virus or anti-fibrosis drug was taken within 6 months.
• Child-Pugh<7 (Stage A)
• The patient or the patient's guardian agrees to participate the trial and sign the informed Consent Form.

Exclusion Criteria

• Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
• 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 anti-viral or anti-fibrosis drug within 6 months.
• Patients who are participating other trials.
• Other situation where PI thinks the patient should be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir + Placebo	Entecavir + Placebo	Tablet with Entrcavir+ Tablet with starch
Entecavir + Fuzheng Huayu Tablet	Entecavir + Fuzheng Huayu Tablet	Tablet with Entrcavir+ Tablet with Fuzheng Huayu

Primary Outcome Measures

Name	Time	Method
Degree of liver fibrosis	48 weeks	The collagen of liver tissue from 48 week post-treatment patients was stained. 3 pathologists read the slides independently and score the slides with Ishak system. If the Ishak score decrease 1 or more than 1 score, then it is recorded as regression.

Trial Locations

Locations (20)

Guangxi Ruikang Hospital; 🇨🇳 Nanning, Guangxi, China

The Fifth Hospital of Shijiazhuang; 🇨🇳 Shijiazhuang, Hebei, China

The Fifth People's Hospital of Anyang; 🇨🇳 Anyang, Henan, China

Jingmen No.1 People's Hospital; 🇨🇳 Jingmen, Hubei, China

Hubei Hospital of TCM; 🇨🇳 Wuhan, Hubei, China

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Hunan University of TCM; 🇨🇳 Changsha, Hunan, China

Huai'an No. 4 People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

The Fifth People's Hospital of Suzhou; 🇨🇳 Suzhou, Jiangsu, China

The Ninth Hospital of Nanchang; 🇨🇳 Nanchang, Jiangxi, China

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