Optimized Treatment and Regression of HBV-induced Early Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-12-31

Brief Summary

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Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.

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Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Entecavir Therapy

Entecavir monotherapy:

entecavir, 0.5mg, qd, oral, for 2 years.

Group Type ACTIVE_COMPARATOR

entecavir

Intervention Type DRUG

anti-viral therapy

Entecavir plus Thymosin-α

entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.

Group Type EXPERIMENTAL

entecavir

Intervention Type DRUG

anti-viral therapy

Thymosin-α

Intervention Type DRUG

antiviral and antifibrosis therapy

Interventions

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entecavir

anti-viral therapy

Intervention Type DRUG

Thymosin-α

antiviral and antifibrosis therapy

Intervention Type DRUG

Other Intervention Names

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entecavir dispersible tablets Zadaxin

Eligibility Criteria

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Inclusion Criteria

1. Patients from age 18 to 65 years old;
2. Male or female;
3. Treatment-naive patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) who consent to undergo liver biopsy before and after treatment;
4. Patients with HBeAg-positive, HBVDNA\>2×10\<3\>IU/ml or patients with HBeAg-negative, HBVDNA\>2×10\<2\> IU/ml；
5. Agree to be followed up regularly;
6. Signature of written informed consent.

Exclusion Criteria

1. Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
2. Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study;
3. Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases;
4. Patients with baseline AFP level higher than 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/ml for more than three months;
5. Creatinine \>1.5×ULN;
6. Patients with other uncured malignant tumors;
7. Patients with severe diseases of heart, lung, kidney, brain, blood or other organs;
8. Patients with any other reasons not suitable for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hong You

Vice-Director of Liver Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong You, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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