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

CHRONIC HEPATITIS B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354653
• Other study ID #: NUC 30956
• Status: Completed
• Phase: Phase 4
• Start date: February 9, 2002
• Est. completion date: January 23, 2007

Study information

• Verified date: February 2020
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 23, 2007
• Est. primary completion date: January 23, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CHRONIC HEPATITIS B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• LAMIVUDINE

Locations

Country	Name	City	State
Iran, Islamic Republic of	GSK Clinical Trials Call Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Partial response, histological improvement (at 24 months). Sustained complete response, sustained partial response at 30 months.