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A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C

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.
 
ClinicalTrials.gov Identifier: NCT00118768
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : March 2, 2009
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

Brief Summary:
This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: valopicitabine Drug: Pegylated Interferon Alfa Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 175 participants
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 the Combination of Pegylated Interferon Alfa Plus NM283 (Valopicitabine) in Treatment-Naive Patients With Chronic Hepatitis C
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease
  • Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection)
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with HIV or Hepatitis B
  • Other protocol-defined exclusion criteria may apply.

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): NCT00118768


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, California
San Diego, California, United States
San Mateo, California, United States
United States, Colorado
Lakewood, Colorado, United States
United States, Florida
Bradenton, Florida, United States
Gainesville, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Laurel, Maryland, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New Mexico
Alburquerque, New Mexico, United States
United States, New York
New York, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Germantown, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
United States, Washington
Tacoma, Washington, United States
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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ClinicalTrials.gov Identifier: NCT00118768    
Other Study ID Numbers: NV-08A-006
First Posted: July 12, 2005    Key Record Dates
Last Update Posted: March 2, 2009
Last Verified: February 2009
Keywords provided by Merck Sharp & Dohme Corp.:
Genotype-1, Chronic Hepatitis C
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
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs