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

This study has been completed.

First Received on August 31, 2005. Last Updated on October 15, 2008 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

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

U.S. FDA Resources

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

Intervention Details:

Other Names:

Lamivudine
Lamivudine plus Polyethylene glyco-interferon alfa-2b

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

No publications provided

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

Keywords provided by GlaxoSmithKline:

HBeAg-positive
chronic
Hepatitis B

lamivudine
seroconversion
Chronic Hepatitis B

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha

Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Lamivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012