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

Phase 2TerminatedNCT00230490

Bausch Health Americas, Inc.150 enrolled

Overview

Compare the long-term safety of pradefovir to adefovir dipivoxyl

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Hepatitis B, Chronic

Interventions

pradefovir mesylateDRUG

adefovir dipivoxylDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

- Safety: Clinical examinations of laboratory tests

- Efficacy: Change in viral load over time

Secondary Outcomes

- Efficacy: Proportion of patients with undetectable viral load

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.