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A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on 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 devoted 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. healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds 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 allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes 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 effective healthcare possible for their A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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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. A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
2. Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
3. Comparison of Entecavir to Adefovir in chronic HBV patients with hepatic decompensation
4. Treatment of Hepatitis in Patients who are Triple-Infected with HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
5. Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
Related Studies:
Other Hepatitis B Clinical Trials
Other Clinical Trials
Other Hong Kong Clinical Trials
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
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