Clinical trial NCT00044135: A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis B
Keywords: clevudine
hepatitis B
Lead sponsor: Triangle Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital, Jefferson Medical College
state: Pennsylvania
city: Vancouver
country: Canada
facility: Viridae
city: Vancouver
country: Canada
facility: University of British Columbia, Downtown Infectious Disease Clinic
city: Hong Kong
country: China
facility: Prince of Wales Hospital, Department of Medicine and Therapeutics
city: Hong Kong
country: China
facility: The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital
city: Clichy
country: France
facility: Hospital Beaujon, Service Hepatologie Centre Pierre Abrami
city: Lyon
country: France
facility: Hospital Dieu, Service Hepatogastroenterologie-endoscopie
city: Paris
country: France
facility: Hospital St Louis, Service de Medecine Interne
city: Vandoeuvre
country: France
facility: Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie
city: Singapore
country: Singapore
facility: National University Hospital, Division of Gastroenterology, Department of Medicine
Study officials:
References: