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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2002 by Triangle Pharmaceuticals.
Recruitment status was:  Active, not recruiting
Information provided by:
Triangle Pharmaceuticals Identifier:
First received: August 20, 2002
Last updated: June 23, 2005
Last verified: November 2002
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.

Condition Intervention Phase
Hepatitis B Drug: clevudine (drug) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Triangle Pharmaceuticals:

Estimated Enrollment: 30
Study Start Date: August 2002

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00044135

United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Pennsylvania
Thomas Jefferson University Hospital, Jefferson Medical College
Philadelphia, Pennsylvania, United States, 19107
Vancouver, Canada, V6Z1Y8
University of British Columbia, Downtown Infectious Disease Clinic
Vancouver, Canada, V6Z2C7
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
Hong Kong, China
Hospital Beaujon, Service Hepatologie Centre Pierre Abrami
Clichy, France, 92118
Hospital Dieu, Service Hepatogastroenterologie-endoscopie
Lyon, France, 69288
Hospital St Louis, Service de Medecine Interne
Paris, France, 75010
Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie
Vandoeuvre, France, 54511
National University Hospital, Division of Gastroenterology, Department of Medicine
Singapore, Singapore, 119074
Sponsors and Collaborators
Triangle Pharmaceuticals
  More Information Identifier: NCT00044135     History of Changes
Other Study ID Numbers: L-FMAU-102 B
Study First Received: August 20, 2002
Last Updated: June 23, 2005

Keywords provided by Triangle Pharmaceuticals:
hepatitis B

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents processed this record on August 21, 2017