Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Compare the long-term safety of pradefovir to adefovir dipivoxyl

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Adefovir; Adefovir dipivoxil; Pradefovir

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