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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00230503
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
  • Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
  • Select the dose of pradefovir for Phase 3 studies

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: pradefovir mesylate Drug: adefovir dipivoxyl Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Study Start Date : June 2004
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. - Safety: Clinical examinations of laboratory tests
  2. - Efficacy: Change in viral load over time

Secondary Outcome Measures :
  1. - Efficacy: Proportion of patients with undetectable viral load


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230503


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

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00230503     History of Changes
Other Study ID Numbers: RNA200103-201
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents