Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Phase 2
Terminated
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT00230490
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
Compare the long-term safety of pradefovir to adefovir dipivoxyl
- Detailed Description
* Compare the long-term safety of pradefovir to adefovir dipivoxyl
* Monitor development of resistance
* Evaluate virologic and biochemical response
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Patients who completed 48 weeks of treatment in study RNA200103-201
Exclusion Criteria
- Patients who were determined to be treatment failures in study RNA200103-201
- Patients who experienced a serious adverse event judged to be related to study drug in study RNA200103-201
- Patients with a serum creatinine greater than 2.0 mg/dl on two consecutive determinations in study RNA200103-201
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