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Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00230503
First received: September 28, 2005
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose
  • Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
  • Select the dose of pradefovir for Phase 3 studies

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

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: 220
Study Start Date: June 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:
  • Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
  • Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment
  • Select the dose of pradefovir for Phase 3 studies
  • Determine the pharacokinetic profiles of four oral doses of pradefovir
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Compensated chronic HBV Infection
  • No prior treatment with adefovir dipivoxil
  • No interferon or lamivudine treatment for three months prior to enrollment
  • HBeAg positive or negative
  • HBV DNA viral load greater than 500,000 copies per mL
  • ALT between 1.2 and 10 times ULN

Exclusion Criteria:

  • Positive HIV, HCV, and/or HDV serology
  • History of renal tubular necrosis
  • Serum creatinine greater than 2.0 mg/dl
  • History of organ transplant or use of immunosuppresive drugs
  • Pregnant or breast-feeding females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230503

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: NCT00230503     History of Changes
Other Study ID Numbers: RNA200103-201
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 May 21, 2013