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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044135
Recruitment Status : Unknown
Verified November 2002 by Triangle Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : August 21, 2002
Last Update Posted : June 24, 2005
Information provided by:
Triangle Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B Drug: clevudine (drug) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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.
Study Start Date : August 2002

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044135

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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
Layout table for additonal information Identifier: NCT00044135    
Other Study ID Numbers: L-FMAU-102 B
First Posted: August 21, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2002
Keywords provided by Triangle Pharmaceuticals:
hepatitis B
Additional relevant MeSH terms:
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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