Clinical trial NCT03919565: Optimized Treatment of Peginterferon Alfa 2a/2b in Anti-virus Treatment Naive Patients With HBV Related Liver Fibrosis
Official title: Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Naive Patients With Hepatitis b Virus Related Liver Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B
Liver Fibrosis
Keywords: hepatitis b virus
peginterferon alfa
liver fibrosis
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of level of liver fibrosis after anti-virus treatment
timeFrame: 48 week, 144 week
Secondary outcomes:
measure: Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment
timeFrame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
measure: Ratio of patients with hepatitis B e antigen seroconversion after anti-virus treatment
timeFrame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
measure: Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment
timeFrame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: