Open-Label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Information source: Valeant Pharmaceuticals North America
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B, Chronic
Intervention: pradefovir mesylate (Drug); adefovir dipivoxyl (Drug)
Phase: Phase 2
Status: No longer recruiting
Sponsored by: Valeant Pharmaceuticals North America
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: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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: September 28, 2005
|
