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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Adefovir dipivoxil; Drug: Lamivudine; Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02598063

ML18376

Details and patient eligibility

About

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.

Enrollment: 255 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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255 participants in 2 patient groups

ADV + Lamivudine

Active Comparator group

Description:

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.

Treatment:

Drug: Lamivudine

Drug: Adefovir dipivoxil

Peginterferon alfa-2a + Lamivudine

Experimental group

Description:

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.

Treatment:

Drug: Peginterferon alfa-2a

Drug: Lamivudine