Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201
Overview
Compare the long-term safety of pradefovir to adefovir dipivoxyl
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
Detailed Description
– Compare the long-term safety of pradefovir to adefovir dipivoxyl – Monitor development of resistance – Evaluate virologic and biochemical response
Interventions
- Drug: pradefovir mesylate
- Drug: adefovir dipivoxyl
Clinical Trial Outcome Measures
Primary Measures
- – Safety: Clinical examinations of laboratory tests
- – Efficacy: Change in viral load over time
Secondary Measures
- – Efficacy: Proportion of patients with undetectable viral load
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Bausch Health Americas, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ralph T. Doyle, Study Director, Bausch Health Americas, Inc.
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