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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

March 17, 2006
June 21, 2012
November 2005
Not Provided
  • 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
  • - 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
Complete list of historical versions of study NCT00305383 on ClinicalTrials.gov Archive Site
Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.
- Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.
Not Provided
Not Provided
 
Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C
Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Viramidine
  • Drug: Peginterferon alfa-2b
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
May 2007
Not Provided

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00305383
RNA003142-202
Not Provided
Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
Not Provided
Study Director: Ralph T. Doyle Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP