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Open-Label Treatment Extension Study for Patients Who Complete Study RNA200103-201
This study has been terminated.
Sponsored by: Valeant Pharmaceuticals North America
Information provided by: Valeant Pharmaceuticals North America
ClinicalTrials.gov Identifier: NCT00230490
  Purpose

Compare the long-term safety of pradefovir to adefovir dipivoxyl


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

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Hepatitis B Vaccines Adefovir dipivoxil Adefovir Pradefovir Mesylate Pradefovir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Open-Label Treatment Extension Study for Patients Who Complete Study RNA200103-201

Further study details as provided by Valeant Pharmaceuticals North America:

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
No Contacts or Locations Provided
  More Information

Study ID Numbers: RNA200103-202
Study First Received: September 28, 2005
Last Updated: February 29, 2008
ClinicalTrials.gov Identifier: NCT00230490  
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals North America:
Hepatitis B, Chronic
Hepatitis B Virus
Pradefovir Mesylate
Adefovir Dipivoxyl

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis B, Chronic
 Hepatitis B
Hepatitis, Viral, Human
Adefovir dipivoxil
DNA Virus Infections
Adefovir

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
 Antiviral Agents
Hepadnaviridae Infections
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009



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