Back to resultsA Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone
Primary Purpose
CHRONIC HEPATITIS B
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
LAMIVUDINE
Sponsored by
About this trial
This is an interventional treatment trial for CHRONIC HEPATITIS B focused on measuring HBeAg, HBV, CHRONIC HEPATITIS, lamivudine
Eligibility 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.
Sites / Locations
- GSK Clinical Trials Call Center
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354653
Brief Title
A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone
Official Title
AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 9, 2002 (Actual)
Primary Completion Date
January 23, 2007 (Actual)
Study Completion Date
January 23, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHRONIC HEPATITIS B
Keywords
HBeAg, HBV, CHRONIC HEPATITIS, lamivudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
LAMIVUDINE
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Partial response, histological improvement (at 24 months). Sustained complete response, sustained partial response at 30 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Tehran
ZIP/Postal Code
1919954186
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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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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