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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00354653

Enrollment

100

Registered

2006-07-20

Start date

2002-02-09

Completion date

2007-01-23

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHRONIC HEPATITIS B

Keywords

HBeAg, HBV, CHRONIC HEPATITIS, lamivudine

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.

Interventions

DRUGLAMIVUDINE

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026