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

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ClinicalTrials.gov Identifier: NCT00354653
Recruitment Status : Unknown
Verified July 2007 by GlaxoSmithKline.
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2006
Last Update Posted : July 25, 2007
Sponsor:
Information provided by:
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: LAMIVUDINE Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-Core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN.
Study Start Date : February 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Lamivudine




Primary Outcome Measures :
  1. 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 :
  1. Partial response, histological improvement (at 24 months). Sustained complete response, sustained partial response at 30 months.


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354653


Locations
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Iran, Islamic Republic of
GSK Clinical Trials Call Center
Tehran, Iran, Islamic Republic of, 1919954186
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline

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ClinicalTrials.gov Identifier: NCT00354653     History of Changes
Other Study ID Numbers: NUC 30956
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2007
Keywords provided by GlaxoSmithKline:
HBeAg
HBV
CHRONIC HEPATITIS
lamivudine
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents