A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

Phase 4

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: peginterferon alfa-2a [PEGASYS]; Drug: Adefovir

• Registration Number: NCT01086085
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Study Start: 2010-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

• Adult patients >/=18 years of age
• HBeAg positive chronic hepatitis B
• Compensated liver disease

Exclusion Criteria

• Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
• Antiviral, anti-neoplastic or immunomodulatory treatment
• Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
• Evidence of decompensated liver disease
• Chronic liver disease other than viral hepatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	peginterferon alfa-2a [PEGASYS]	-
C	peginterferon alfa-2a [PEGASYS]	-
D	Adefovir	-
D	peginterferon alfa-2a [PEGASYS]	-
B	peginterferon alfa-2a [PEGASYS]	-

Primary Outcome Measures

Name	Time	Method
Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)	Weeks 72, 96, 120

Secondary Outcome Measures

Name	Time	Method
Safety: Adverse Events	From baseline to Week 120
Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml	Weeks 24, 48, 72, 96, 120