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

Sponsor

Triangle Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00044135

Collaborator

(none)

Enrollment

Locations

2.7

Patients Per Site

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Aug 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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