Skip to main content
OpenTrials
Completed

NCT Number: NCT00140725

Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)

This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Genital Diseases Graft vs Host Disease HIV Infections HIV Seropositivity Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
  • Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.

Exclusion criteria

  • Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.

Treatment and study plan

Lamivudine plus Polyethylene glyco-interferon alfa-2b

Drug

Lamivudine

Drug

Other names: Lamivudine plus Polyethylene glyco-interferon alfa-2b

Primary outcomes

  1. Proportion of patients with HBeAg seroconversion to anti-HBe

Secondary outcomes

  1. Normalization of alanine aminotransferase (ALT)

  2. Undetectable HBV DNA

  3. Histologic improvement

  4. Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)

Important dates

Study start
2000
First posted
Sep 1, 2005
Registry last updated
Oct 16, 2008

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.