Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive (VISER2)
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| ClinicalTrials.gov Identifier: NCT00093093 |
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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.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Hepatitis C | Drug: Viramidine Drug: Ribavirin Drug: pegylated interferon alfa-2a | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 900 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C |
| Study Start Date : | June 2004 |
| Actual Primary Completion Date : | May 2006 |
| Actual Study Completion Date : | May 2006 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ribavirin
Primary Outcome Measures :
- - 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.
Secondary Outcome Measures :
- - 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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, ophthalmologic disorders including severe retinopathy, or immune mediated disease
- Pregnant or breast-feeding patients
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093093
Locations
Show 100 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
| Study Director: | Ralph T. Doyle | Bausch Health Americas, Inc. |
| Responsible Party: | Bausch Health Americas, Inc. |
| ClinicalTrials.gov Identifier: | NCT00093093 |
| Other Study ID Numbers: |
RNA003142-302 |
| First Posted: | October 4, 2004 Key Record Dates |
| Last Update Posted: | June 22, 2012 |
| Last Verified: | June 2012 |
Keywords provided by Bausch Health Americas, Inc.:
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Viramidine Ribavirin Valeant Hepatitis C Pegylated interferon alfa-2a |
Additional relevant MeSH terms:
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Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Interferons Ribavirin Interferon-alpha Interferon alpha-2 Peginterferon alfa-2a Ribavirin amidine Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |