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

This study has been terminated.
(Adverse findings from nonclinical carcinogenicity studies.)
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00230490
First received: September 28, 2005
Last updated: June 21, 2012
Last verified: June 2012
  Purpose
Compare the long-term safety of pradefovir to adefovir dipivoxyl

Condition Intervention Phase
Hepatitis B, Chronic
Drug: pradefovir mesylate
Drug: adefovir dipivoxyl
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Treatment Extension Study for Patients Who Complete Study RNA200103-201

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

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

Estimated Enrollment: 150
Study Start Date: June 2005
Study Completion Date: May 2007
Detailed Description:
  • Compare the long-term safety of pradefovir to adefovir dipivoxyl
  • Monitor development of resistance
  • Evaluate virologic and biochemical response
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230490

Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Ralph T. Doyle Valeant Pharmaceuticals International, Inc.
  More Information

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00230490     History of Changes
Other Study ID Numbers: RNA200103-202 
Study First Received: September 28, 2005
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Hepatitis B, Chronic
Hepatitis B Virus
Pradefovir Mesylate
Adefovir Dipivoxyl

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on September 27, 2016