Optimized Treatment and Regression of HBV-induced Liver Fibrosis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01938781

Enrollment

400

Registered

2013-09-10

Start date

2013-06-30

Completion date

2016-12-31

Last updated

2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis

Keywords

Hepatitis B, Liver fibrosis, Regression, Efficacy

Brief summary

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.

Interventions

DRUGentecavir

antiviral therapy

DRUGPeg-IFN

antiviral and antifibrosis therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Regression Rate of HBV-induced Liver Fibrosis	1.5 to 2 years	Fibrosis regression of 1 point by Ishak scoring system

Secondary

Measure	Time frame	Description
HBVDNA undetectable rate	1 year and 2 years	The HBVDNA undetectable rate after 1 year and 2-year treatment
Fibroscan scores	1 year and 2 years	Fibroscan scores after 1 and 2-year treatment
Life Quality	1 year and 2 years	Life quality after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
Incidence of drug resistance	1 year and 2 years	Incidence of drug resistance after 1 and 2-year treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026