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Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00230958
First Posted: October 3, 2005
Last Update Posted: June 22, 2012
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.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
September 29, 2005
October 3, 2005
June 22, 2012
December 2003
January 2006   (Final data collection date for primary outcome measure)
  • - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
  • - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.
Same as current
Complete list of historical versions of study NCT00230958 on ClinicalTrials.gov Archive Site
  • - Efficacy: Undetectable plasma HCV RNA at treatment week 24
  • - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
  • - Safety: Monitoring of adverse events
  • - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related
Same as current
Not Provided
Not Provided
 
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive
Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.
Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2b to treatment-naive patients with chronic hepatitis C (CHC)
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Viramidine
  • Drug: Ribavirin
  • Drug: pegylated interferon 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.
 
Completed
900
January 2006
January 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treatment-naive patients with compensated chronic hepatitis C.
  • HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).

Exclusion Criteria:

  • Severe neuropsychiatric disorders
  • History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, opthalmologic disorders including severe retinopathy, or immune mediated disease
  • Pregnant or breast-feeding patients
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00230958
RNA003142-301
Not Provided
Not Provided
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