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Completed

NCT Number: NCT02598063

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adefovir dipivoxil

Drug

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

Lamivudine

Drug

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

Peginterferon alfa-2a

Drug

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

Other names: Pegasys

Primary outcomes

  1. HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72

    Time frame: Week 72

Secondary outcomes

  1. Loss of HBeAg

    Time frame: Week 48, and 72

  2. Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)

    Time frame: Week 48, and 72

  3. Alanine transaminase (ALT) normalization

    Time frame: Week 48, and 72

  4. Hepatitis B surface antigen (HBsAg) seroconversion

    Time frame: Week 48, and 72

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 5, 2015
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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