Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive (VISER2)
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ClinicalTrials.gov Identifier: NCT00093093 |
Recruitment Status :
Completed
First Posted : October 4, 2004
Last Update Posted : June 22, 2012
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Sponsor:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | September 30, 2004 | |||
First Posted Date ICMJE | October 4, 2004 | |||
Last Update Posted Date | June 22, 2012 | |||
Study Start Date ICMJE | June 2004 | |||
Actual Primary Completion Date | May 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive | |||
Official Title ICMJE | Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C | |||
Brief Summary | The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment. | |||
Detailed Description | Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC) | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Chronic Hepatitis C | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
900 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2006 | |||
Actual Primary Completion Date | May 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Canada, France, Israel, Italy, Poland, Puerto Rico, Russian Federation, Spain, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00093093 | |||
Other Study ID Numbers ICMJE | RNA003142-302 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Bausch Health Americas, Inc. | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Bausch Health Americas, Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bausch Health Americas, Inc. | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |