Optimized Treatment and Regression of HBV-induced Liver Fibrosis

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

400 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 liver fibrosis S2/S3 (similar to metavir F2/F3, Ishak 2/3/4) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus pegylated interferon (peg-IFN) 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, thyroid function, 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 Fibrosis

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 monotherapy

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

Group Type ACTIVE_COMPARATOR

entecavir

Intervention Type DRUG

antiviral therapy

Entecavir plus peg-IFN Therapy

entecavir combined peg-IFN in the middle 1 year.

Group Type EXPERIMENTAL

entecavir

Intervention Type DRUG

antiviral therapy

Peg-IFN

Intervention Type DRUG

antiviral and antifibrosis therapy

Interventions

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entecavir

antiviral therapy

Intervention Type DRUG

Peg-IFN

antiviral and antifibrosis therapy

Intervention Type DRUG

Other Intervention Names

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entecavir dispersible tablets Pegasys

Eligibility Criteria

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Inclusion Criteria

1. Ages from 18 to 65 years old;
2. Male or female;
3. Treatment-naive patients with chronic HBV-induced fibrosis S2/S3 (similar to F2/F3, Ishak 2/3/4), who consent to undergo liver biopsy before and after treatment;
4. Patients with HBeAg-positive, HBVDNA\>2×10\<4\> IU/ml or with HBeAg-negative, HBVDNA\>2×10\<3\> IU/ml;
5. Agree to be follow-up regularly;
6. signature of written inform 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, interferon, or their components, and those considered not suitable for medications used in this study;
3. Patients coinfection with HCV or HIV, 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 continuous 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 system or other organs;
8. Patients with severe neurological or psychological disease (e.g. epilepsy, depression, mania and schizophrenia);
9. Patients with poorly controlled diabetes, hypertension or thyroid disease;
10. 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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