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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00140725

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b Drug: Lamivudine	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Lamivudine Hepatitis B Vaccines Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Proportion of patients with HBeAg seroconversion to anti-HBe

Secondary Outcome Measures:

Normalization of alanine aminotransferase (ALT)
Undetectable HBV DNA
Histologic improvement
Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment

Estimated Enrollment:	160
Study Start Date:	April 2000

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140725

Locations

Hong Kong
GSK Investigational Site
Shatin, Hong Kong

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NUC30938
Study First Received:	August 31, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00140725
Health Authority:	Hong Kong: Department of Health

Keywords provided by GlaxoSmithKline:

HBeAg-positive
chronic
Hepatitis B

lamivudine
seroconversion
Chronic Hepatitis B

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Lamivudine
Hepatitis

Virus Diseases
Digestive System Diseases
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Hepadnaviridae Infections

Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009