Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C

This study has been terminated.
(Dose levels were determined to be subtherapeutic)
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00305383
First received: March 17, 2006
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Viramidine
Drug: Peginterferon alfa-2b
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Efficacy: The proportion of patients with hepatitis C virus (HCV) RNA undetectable or with at least a 2-log drop from baseline at CT Week 4 in the viramidine pre-load group versus the viramidine standard dosing group.
  • Safety: Evaluation of adverse events (AEs).
  • Safety: Physical exams
  • Safety: Vital signs
  • Safety: Laboratory tests

Secondary Outcome Measures:
  • Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.

Estimated Enrollment: 100
Study Start Date: November 2005
Study Completion Date: May 2007
Detailed Description:

This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients
  • Body weight greater than 61 kg and not more than 87.3 kg
  • HCV RNA greater than 2 million copies/mL
  • Elevated measured or historical alanine aminotransferase
  • Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males
  • Calculated creatinine clearance greater than 70 mL/min

Exclusion Criteria:

  • Cirrhosis of the liver
  • Alanine aminotransferase greater than 3 times the upper limit of normal
  • Severe neuropsychiatric disorders
  • History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
  • Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305383

Locations
United States, California
University of Southern California -- Keck School of Medicine
Los Angeles, California, United States, 90033
San Mateo Medical Center
San Mateo, California, United States, 94403
United States, Florida
Bach and Godofsky
Bradenton, Florida, United States, 34205
University of Miami -- Center for Liver Diseases
Miami, Florida, United States, 33136
United States, Georgia
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
United States, Maryland
Maryland Digestive Disease Research
Laurel, Maryland, United States, 20707
United States, New Jersey
Atlantic Gastroenterology Associates
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Liver Center of Long Island
Plainview, New York, United States, 11803
United States, Pennsylvania
Thomas Jefferson University -- Gastroenterology and Hepatology
Philadelphia, Pennsylvania, United States, 19107
United States, Utah
Mountain West Gastroenterology -- Research Office
Salt Lake City, Utah, United States, 84121
United States, Virginia
Metropolitan Research -- Georgetown Medical Center
Fairfax, Virginia, United States, 22031
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: NCT00305383     History of Changes
Other Study ID Numbers: RNA003142-202
Study First Received: March 17, 2006
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Viramidine
Peginterferon alfa-2b
Valeant
Hepatitis C
Rapid virologic response
HCV RNA

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014