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

This study has been terminated.

( Adverse findings from nonclinical carcinogenicity studies. )

First Received on September 28, 2005. Last Updated on February 29, 2008 History of Changes

Sponsor:	Valeant Pharmaceuticals International, Inc.
Information provided by:	Valeant Pharmaceuticals International, Inc.
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

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Adefovir Adefovir dipivoxil Pradefovir Pradefovir Mesylate

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

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00230490 History of Changes
Other Study ID Numbers:	RNA200103-202
Study First Received:	September 28, 2005
Last Updated:	February 29, 2008
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 February 09, 2012