Optimized Treatment of Peginterferon Alfa 2a/2b in Anti-virus Treatment Naive Patients With HBV Related Liver Fibrosis

Not Applicable

• Conditions: Liver Fibrosis; Hepatitis B
• Interventions: Drug: Peginterferon Alfa-2a; Drug: Tenofovir Disoproxil Fumarate; Drug: Peginterferon Alfa-2b

• Registration Number: NCT03919565
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with HBV related liver fibrosis.

Detailed Description

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment naive patients with HBV related liver fibrosis.

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Study First Posted: 2019-04-18
• Last Update Posted: 2019-04-19
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
2. Age from 18 to 55 years old;
3. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
4. Portal vein diameter ≤ 12 mm from liver ultrasound;
5. Without treatment of anti-virus treatment ever before.

Exclusion Criteria

1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
2. Pregnancy or lactation;
3. Other active liver diseases；
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Patients can not follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peginterferon alfa group	Peginterferon Alfa-2a	40 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks.
TDF group	Tenofovir Disoproxil Fumarate	80 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 144 weeks.
Peginterferon alfa group	Peginterferon Alfa-2b	40 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks.

Primary Outcome Measures

Name	Time	Method
Change of level of liver fibrosis after anti-virus treatment	48 week, 144 week	Liver biopsy or fibroscan would be accessed to know the change of level of liver fibrosis at 48 and 144 weeks after anti-virus treatment.

Secondary Outcome Measures

Name	Time	Method
Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment	24 week, 48 week, 72 week, 96 week, 120 week,144 week	Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 6 time points after anti-virus treatment.
Ratio of patients with hepatitis B e antigen seroconversion after anti-virus treatment	24 week, 48 week, 72 week, 96 week, 120 week,144 week	Hepatitis b e antigen and hepatitis b e antibody would be tested to know the ratio of patients with negative hepatitis B e antigen and positive hepatitis B e antibody at 6 time points after anti-virus treatment.
Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment	24 week, 48 week, 72 week, 96 week, 120 week,144 week	Hepatitis b surface antigen and hepatitis b surface antibody would be tested to know the ratio of patients with negative hepatitis B surface antigen and positive hepatitis B surface antibody at 6 time points after anti-virus treatment.

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China