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Completed

NCT Number: NCT00354653

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Clinical Trials Call Center

Tehran, 1919954186, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lamivudine

Drug

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study title

AN OPEN STUDY OF LAMIVUDINE TREATMENT IN ADULT HBeAg NEGATIVE (Presumed Pre-core Mutant) CHRONIC HEPATITIS B PATIENTS IN IRAN.

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Jul 20, 2006
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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