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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
History of Changes
  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:

U.S. FDA Resources

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
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
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

No publications provided

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 A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Hepatitis, Chronic
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on June 18, 2013