Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Phase 2
Completed
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT00230503
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
* Select the dose of pradefovir for Phase 3 studies
- Detailed Description
* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
* Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment
* Select the dose of pradefovir for Phase 3 studies
* Determine the pharacokinetic profiles of four oral doses of pradefovir
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
- Compensated chronic HBV Infection
- No prior treatment with adefovir dipivoxil
- No interferon or lamivudine treatment for three months prior to enrollment
- HBeAg positive or negative
- HBV DNA viral load greater than 500,000 copies per mL
- ALT between 1.2 and 10 times ULN
Exclusion Criteria
- Positive HIV, HCV, and/or HDV serology
- History of renal tubular necrosis
- Serum creatinine greater than 2.0 mg/dl
- History of organ transplant or use of immunosuppresive drugs
- Pregnant or breast-feeding females
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method - Safety: Clinical examinations of laboratory tests - Efficacy: Change in viral load over time
- Secondary Outcome Measures
Name Time Method - Efficacy: Proportion of patients with undetectable viral load