Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
This study has been completed.
Sponsor:
Idenix Pharmaceuticals
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00120861
First received: July 11, 2005
Last updated: June 9, 2010
Last verified: June 2010
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Purpose
This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: valopicitabine Drug: pegylated interferon Drug: ribavirin |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy |
Resource links provided by NLM:
Further study details as provided by Idenix Pharmaceuticals:
Eligibility
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Documented clinical history compatible with chronic hepatitis C and compensated liver disease
- Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis B or HIV
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120861
Locations
United States, Alabama | |
Birmingham, Alabama, United States | |
United States, California | |
Los Angeles, California, United States | |
San Francisco, California, United States | |
United States, Florida | |
Miami, Florida, United States | |
United States, Maryland | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, Michigan | |
Detroit, Michigan, United States | |
United States, New York | |
New York, New York, United States | |
United States, Texas | |
Dallas, Texas, United States | |
Houston, Texas, United States | |
San Antonio, Texas, United States |
Sponsors and Collaborators
Idenix Pharmaceuticals
More Information
Additional Information:
No publications provided
Keywords provided by Idenix Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
Additional Information:
Related Info 
No publications provided
ClinicalTrials.gov Identifier: | NCT00120861 History of Changes |
Other Study ID Numbers: | NV-08A-004 |
Study First Received: | July 11, 2005 |
Last Updated: | June 9, 2010 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Idenix Pharmaceuticals:
Genotype-1 Previously failed treatment |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Interferons Ribavirin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 16, 2012