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

Tracking Information
First Received Date ^ICMJE	August 20, 2002
Last Updated Date
Start Date ^ICMJE	August 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00044135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
Official Title ^ICMJE	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.
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Hepatitis B
Intervention ^ICMJE	Drug: clevudine (drug)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	30
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, China, France

Administrative Information
NCT ID ^ICMJE	NCT00044135
Responsible Party
Study ID Numbers ^ICMJE	L-FMAU-102 B
Study Sponsor ^ICMJE	Triangle Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Triangle Pharmaceuticals
Verification Date	November 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP