A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B

Phase 4

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Adefovir dipivoxil; Drug: Lamivudine; Drug: Peginterferon alfa-2a

• Registration Number: NCT02598063
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• Adult participants 18-65 years of age
• Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (>=) 6 months
• Receiving lamivudine currently, and for >=6 months
• hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased >=2 log during lamivudine treatment on >=1 occasion
• Absence of cirrhosis confirmed by liver biopsy in previous 6 months

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Exclusion Criteria

• Other drugs with activity against HBV within the prior 6 months, except lamivudine
• Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
• Decompensated liver disease
• Medical condition associated with another chronic liver disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADV + Lamivudine	Lamivudine	Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.
ADV + Lamivudine	Adefovir dipivoxil	Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.
Peginterferon alfa-2a + Lamivudine	Peginterferon alfa-2a	Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.
Peginterferon alfa-2a + Lamivudine	Lamivudine	Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.

Primary Outcome Measures

Name	Time	Method
HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72	Week 72

Secondary Outcome Measures

Name	Time	Method
Alanine transaminase (ALT) normalization	Week 48, and 72
Hepatitis B surface antigen (HBsAg) seroconversion	Week 48, and 72
Loss of HBeAg	Week 48, and 72
Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)	Week 48, and 72