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

A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02598063

Enrollment

255

Registered

2015-11-05

Start date

2005-10-31

Completion date

2009-04-30

Last updated

2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

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.

Interventions

DRUGAdefovir dipivoxil

ADV will be administered orally at a dose of 10 mg QD for 72 weeks.

DRUGLamivudine

Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.

DRUGPeginterferon alfa-2a

Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

China, Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026