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

Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00044135
• Other study ID #: L-FMAU-102 B
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 20, 2002
• Last updated: June 23, 2005
• Start date: August 2002

Study information

• Verified date: November 2002
• Source: Triangle Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Drug:
• clevudine (drug)

Locations

Country	Name	City	State
Canada	University of British Columbia, Downtown Infectious Disease Clinic	Vancouver
Canada	Viridae	Vancouver
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	Hong Kong
France	Hospital Beaujon, Service Hepatologie Centre Pierre Abrami	Clichy
France	Hospital Dieu, Service Hepatogastroenterologie-endoscopie	Lyon
France	Hospital St Louis, Service de Medecine Interne	Paris
France	Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie	Vandoeuvre
Singapore	National University Hospital, Division of Gastroenterology, Department of Medicine	Singapore
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Thomas Jefferson University Hospital, Jefferson Medical College	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Triangle Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  China,  France,  Singapore,