Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Information source: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B, Chronic
Intervention: pradefovir mesylate (Drug); adefovir dipivoxyl (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Valeant Pharmaceuticals International, Inc. Official(s) and/or principal investigator(s): Ralph T. Doyle, Study Director, Affiliation: Valeant Pharmaceuticals International, Inc.
Summary
Compare the long-term safety of pradefovir to adefovir dipivoxyl
Clinical Details
Official title: Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: - Safety: Clinical examinations of laboratory tests- Efficacy: Change in viral load over time
Secondary outcome: - Efficacy: Proportion of patients with undetectable viral load
Detailed description:
- Compare the long-term safety of pradefovir to adefovir dipivoxyl
- Monitor development of resistance
- Evaluate virologic and biochemical response
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2005
Last updated: June 21, 2012
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