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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.