Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA

Phase 3

Completed

• Conditions: Antiviral Treatment of Chronic Hepatitis B
• Interventions: Drug: Pegasys(Roche); Drug: Entecavir

• Registration Number: NCT01892241
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.

Detailed Description

It was a prospective, non-randomized, open-label study that evaluated the efficacy and safety of pegasys treatment in chronic hepatitis B patients with spontaneous HBVDNA decline after acute exacerbation.Patients with spontaneous decline of HBV DNA(a decrease of HBV DNA levels of more than 2 log(10) IU/mL as compared to baseline before antiviral treatment) after acute exacerbation (ALT was 10-30ULN，TBIL was 2-20mg/ml，PTA\>60%)were non-randomly divided into 3 groups: group A, B and C. Before treatment, the patients were counselled on the advantages and disadvantages of taking peginterferon or nucleos(t)ide analogue, and the subsequential treatment were decided by themselves. Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks. Group B and C were control group, cases in group B received an continual entecavir therapy(0.5 mg orally once daily) and those in group C didn't accept any antiviral regiment.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-08-22
• Primary Completion: 2012-11
• Study Completion: 2013-02
• Study First Submitted QC: 2013-06-30
• Study First Posted: 2013-07-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-28
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
180µg of peginterferon alfa-2a	Pegasys(Roche)	Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
Entecavir	Entecavir	cases in group B received an continual entecavir therapy(0.5 mg orally once daily)

Primary Outcome Measures

Name	Time	Method
Complete viralogic response	week 96	Complete viralogic response was defined as suppression of HBV DNA to the level below 60IU/mL(detected by Cobas Amplicor HBV Monitor Test, Roche Diagnostics).

Secondary Outcome Measures

Name	Time	Method
Sick leave in patients in different groups	week 48,72 and 96
HBsAg loss and seroconversion	week 24,48,72 and 96	HBsAg loss was defined as HBsAg titre less than 0.05 IU/mL and the HBsAg seroconversion was defined as the loss of HBsAg and the presence of anti-HBs antibody. HBeAg seroconversion was defined as disappearance of HBeAg and appearance of anti-HBe antibody, while HBeAg loss was defined as disappearance of HBeAg only.
ALT normalization	week 24,48,72 and 96	ALT normalization was defined as ALT level less than 40 IU/L(determined by a sequential multiple autoanalyzer).