Active, not recruiting

Study Description:

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.

Viiv Study ID:

NUC 30956


Has Results Document Available
Clinicaltrials.gov Identifier:

NCT00354653


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Hepatitis B

Product

lamivudine

Collaborators

None


Date

February 2002 to January 2007

Type

Interventional

Phase

4


Gender

Both

Age

15 Years - N/A N/A

Accepts Healthy Volunteers

no


Study Documents

This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    Not available

  • Central Contact Phone:

    Not Available

  • Central Contact Email:

    Not Available

Iran, N/A, Tehran 1919954186No longer recruiting

Study Design

  • Primary Purpose: Treatment
  • Allocation: Non-randomized
  • Study Design: Single Group Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Not Available
  • Masked Caregiver: Not Available
  • Masked Investigator: Not Available
  • Masked Assessor: Not Available
Primary Outcomes:

  • 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)
    Timeframe:

Secondary Outcomes:

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

Arms:
  • N/A

Interventions:

  • Drug: LAMIVUDINE

Keyword:

  • HBeAg, HBV, CHRONIC HEPATITIS, lamivudine
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 100

Clinical Publications: