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 because the information has not been verified recently.

Verified November 2002 by Triangle Pharmaceuticals. Recruitment status was Active, not recruiting

First Received on August 20, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	Triangle Pharmaceuticals
Information provided by:	Triangle Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00044135

Purpose

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: 2'-Fluoro-5-methyl-beta-L-arabinofuranosyluracil Recombinant hepatitis B vaccine Hepatitis B Vaccines Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Triangle Pharmaceuticals:

Estimated Enrollment:	30
Study Start Date:	August 2002

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044135

Locations

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
Canada
University of British Columbia, Downtown Infectious Disease Clinic
Vancouver, Canada, V6Z2C7
Viridae
Vancouver, Canada, V6Z1Y8
China
The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital
Hong Kong, China
Prince of Wales Hospital, Department of Medicine and Therapeutics
Hong Kong, China
France
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

Sponsors and Collaborators

Triangle Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00044135 History of Changes
Other Study ID Numbers:	L-FMAU-102 B
Study First Received:	August 20, 2002
Last Updated:	June 23, 2005
Health Authority:	Unspecified

Keywords provided by Triangle Pharmaceuticals:

clevudine
hepatitis B

Additional relevant MeSH terms:

Hepatitis
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
2'-fluoro-5-methylarabinosyluracil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012