A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.

June 23, 2005 updated by: Triangle Pharmaceuticals

A Phase II, Randomized, Partially-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of 12 Weeks of Treatment with Clevudine (10 mg, 30 mg or 50 mg QD) in Patients Infected with Hepatitis B Virus.

The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Vancouver, Canada, V6Z1Y8
        • Viridae
      • Vancouver, Canada, V6Z2C7
        • University of British Columbia, Downtown Infectious Disease Clinic
  • China
      • Hong Kong, China
        • Prince of Wales Hospital, Department of Medicine and Therapeutics
      • Hong Kong, China
        • The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital
  • France
      • Clichy, France, 92118
        • Hospital Beaujon, Service Hepatologie Centre Pierre Abrami
      • Lyon, France, 69288
        • Hospital Dieu, Service Hepatogastroenterologie-endoscopie
      • Paris, France, 75010
        • Hospital St Louis, Service de Medecine Interne
      • Vandoeuvre, France, 54511
        • Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital, Division of Gastroenterology, Department of Medicine
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital, Jefferson Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HBV DNA positive with DNA levels at screening greater than or equal to 3,000,000 copies/mL.
  • Documented to be HBsAg positive for > 6 months OR HBsAg positive and IgM anti-HBc negative and anti-HBs negative. Patients may be HBeAg positive, and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive.
  • HBeAg positive and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive with positive HBsAg for the previous 6 months
  • AST and ALT levels which are less than or equal to 10 times the upper limit of normal.
  • Bilirubin levels less than or equal to 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.

Exclusion Criteria:

  • Currently receiving antiviral, immunomodulatory or corticosteroid therapy
  • Previous treatment with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection
  • Previous treatment with interferon must have ended at least 6 months prior to screening visit
  • History of ascites, variceal hemorrhage or hepatic encephalopathy
  • Co-infection with HCV or HIV
  • Evidence of cirrhosis or hepatocellular carcinoma (alpha fetoprotein)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Triangle Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Registration Dates

First Submitted

August 20, 2002

First Submitted That Met QC Criteria

August 20, 2002

First Posted (ESTIMATE)

August 21, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L-FMAU-102 B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B

Clinical Trials on clevudine (drug)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe