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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00116805 |
This study is designed to evaluate the safety and antiviral activity of tenofovir compared to Hepsera for the treatment of HBeAg positive chronic hepatitis B. Patients will either receive tenofovir or the approved hepatitis B therapy, Hepsera. After 48 weeks all patients will be switched to open label tenofovir.
Condition | Intervention | Phase |
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Chronic Hepatitis B |
Drug: tenofovir disoproxil fumarate Drug: adefovir dipivoxil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B |
Enrollment: | 266 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | June 2014 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Tenofovir Disoproxil Fumarate 300 mg once daily and then switch to open label tenofovir disoproxil fumarate 300 mg once daily for an additional 336 weeks
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Drug: tenofovir disoproxil fumarate
300 mg once daily for 48 weeks and then open label tenofovir disoproxil fumarate 300 mg once daily for an additional 336 weeks
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B: Active Comparator
Adefovir Dipivoxil10 mg once daily and then switch to open label tenofovir disoproxil fumarate 300 mg once daily for an additional 336 weeks
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Drug: adefovir dipivoxil
10 mg once daily for 48 weeks and then open label tenofovir disoproxil fumarate 300 mg once daily for an additional 336 weeks
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Efficacy of tenofovir versus Hepsera will be evaluated for histologic improvement, reductions in serum HBV DNA, changes in liver enzymes, and the generation of antibody to the virus. Safety will be assessed by evaluating adverse events, laboratory abnormalities and the development of drug-resistant mutations. After 48 weeks, all patients will receive tenofovir and the efficacy and safety of tenofovir will be monitored for an additional 336 weeks.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for participation in this study.
Active HBeAg positive chronic HBV infection, with all of the following:
Exclusion Criteria:
A patient who meets any of the following exclusion criteria is not to be enrolled in this study.
Study Chair: | Elsa Mondou, MD | Gilead Sciences |
Responsible Party: | Gilead Sciences ( Elsa Mondou, MD ) |
Study ID Numbers: | GS-US-174-0103 |
Study First Received: | June 30, 2005 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00116805 |
Health Authority: | United States: Food and Drug Administration |
tenofovir adefovir hepatitis B HBeAg Positive |
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis Virus Diseases Digestive System Diseases Hepatitis B, Chronic |
Hepatitis B Tenofovir DNA Virus Infections Adefovir dipivoxil Adefovir Tenofovir disoproxil |
Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors |