A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00354653

Purpose

The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited. Limited sustained response was observed post-treatment following a one year treatment period. Whether these results can be applied to patients in Iran is uncertain. This study is therefore intended to further assess the efficacy profile after two years of open treatment in the adult Iranian population.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: LAMIVUDINE	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Lamivudine Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-Core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Complete virologic response at Month 24 which is normalisation of alanine aminotransferase (ALT) and disappearance of HBV DNA by NAXCOR(brand name of a virus assay kit)

Secondary Outcome Measures:

Partial response, histological improvement (at 24 months). Sustained complete response, sustained partial response at 30 months.

Estimated Enrollment:	100
Study Start Date:	February 2002

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed active liver disease due to Hepatitis B virus.
Patients must have adequate blood & liver functions.
Female patients of child-bearing potential must be non pregnant and willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
Patients who have serious concurrent illnesses other than hepatitis B like cancer, severe heart disease, uncontrolled diabetes mellitus or AIDS will not be eligible.

Exclusion Criteria:

Persons allergic to lamivudine or suffering from hepatitis C, D or E infection or taking alcohol will not be eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354653

Locations

Iran, Islamic Republic of
GSK Clinical Trials Call Center
Tehran, Iran, Islamic Republic of, 1919954186

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Study ID Numbers:	NUC 30956
Study First Received:	July 19, 2006
Last Updated:	July 24, 2007
ClinicalTrials.gov Identifier:	NCT00354653
Health Authority:	Pakistan: Ministry of Health

Keywords provided by GlaxoSmithKline:

HBeAg
HBV
CHRONIC HEPATITIS
lamivudine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Hepatitis B, Chronic
Hepatitis B
Lamivudine
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009