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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:
ClinicalTrials.gov Identifier:
NCT00120861
First Posted: July 19, 2005
Last Update Posted: June 10, 2010
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:
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: None (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 Merck Sharp & Dohme Corp.:

Study Start Date: January 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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
Merck Sharp & Dohme Corp.
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00120861     History of Changes
Other Study ID Numbers: NV-08A-004
First Submitted: July 11, 2005
First Posted: July 19, 2005
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by Merck Sharp & Dohme Corp.:
Genotype-1
Previously failed treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action