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

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00230490

Collaborator

(none)

150

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

Compare the long-term safety of pradefovir to adefovir dipivoxyl

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic	Drug: pradefovir mesylate Drug: adefovir dipivoxyl	Phase 2

Detailed Description

Compare the long-term safety of pradefovir to adefovir dipivoxyl
Monitor development of resistance
Evaluate virologic and biochemical response

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2005

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

- Safety: Clinical examinations of laboratory tests []
- Efficacy: Change in viral load over time []

Secondary Outcome Measures

- Efficacy: Proportion of patients with undetectable viral load []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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