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A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. Clinical research trials and A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.. A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. clinical trial. Test subjects typically receive the most expert healthcare available for their A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.  A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
For Condition: Hepatitis B
Status: No longer recruiting
Sponsor(s): Triangle Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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)
Total Enrollment: 30
Location and Contact Information:
Hospital Dieu, Service Hepatogastroenterologie-endoscopie
Lyon, , 69288
France
Thomas Jefferson University Hospital, Jefferson Medical College
Philadelphia, Pennsylvania, 19107
United States
Hospital St Louis, Service de Medecine Interne
Paris, , 75010
France
The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital
Hong Kong, ,
China
Viridae
Vancouver, , V6Z1Y8
Canada
University of British Columbia, Downtown Infectious Disease Clinic
Vancouver, , V6Z2C7
Canada
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Hospital Beaujon, Service Hepatologie Centre Pierre Abrami
Clichy, , 92118
France
Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie
Vandoeuvre, , 54511
France
National University Hospital, Division of Gastroenterology, Department of Medicine
Singapore, , 119074
Prince of Wales Hospital, Department of Medicine and Therapeutics
Hong Kong, ,
China
Additional Information:
Study ID Numbers: L-FMAU-102 B;
Study Start Date: August 2002
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044135
Other Hepatitis B Studies:
1. Frequency of Parenteral and Non-Parenteral Exposures to Blood Among Healthcare Workers at the Clinical Center, NIH and at Seven Academic Hospitals in Japan
2. Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
3. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
4. A Phase II Study of the Safety and Efficacy of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients Who Have Hepatitis B Viremia While Being Treated with Lamivudine
5. Comparison of Entecavir to Adefovir in chronic HBV patients with hepatic decompensation
Related Studies:
Other Hepatitis B Clinical Trials
Other Clinical Trials
Other Paris Clinical Trials
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
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