Status:
TERMINATED
Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- Patients who completed 48 weeks of treatment in study RNA200103-201
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00230490
Start Date
June 1 2005
End Date
May 1 2007
Last Update
November 29 2019
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