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

Sponsored by:	Valeant Pharmaceuticals North America
Information provided by:	Valeant Pharmaceuticals North America
ClinicalTrials.gov Identifier:	NCT00093093

Purpose

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	Intervention	Phase
Chronic Hepatitis C	Drug: Viramidine Drug: Ribavirin Drug: pegylated interferon alfa-2a	Phase III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferons Ribavirin amidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Valeant Pharmaceuticals North America:

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

Estimated Enrollment:	900
Study Start Date:	June 2004
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093093

Show 100 Study Locations

Sponsors and Collaborators

Valeant Pharmaceuticals North America

More Information

Study ID Numbers:	RNA003142-302
Study First Received:	September 30, 2004
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00093093
Health Authority:	United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals North America:

Viramidine
Ribavirin
Valeant
Hepatitis C
Pegylated interferon alfa-2a

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009