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Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive 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. Identifier: NCT00120835
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : June 10, 2010
Information provided by:
Merck Sharp & Dohme Corp.

Brief Summary:
This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: valopicitabine Drug: pegylated interferon Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C
Study Start Date : July 2004

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

Inclusion Criteria:

  • Documented clinical history compatible with genotype-1, chronic hepatitis C infection
  • Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant
  • Patient is co-infected with hepatitis B or HIV

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 identifier (NCT number): NCT00120835

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United States, Florida
Bradenton, Florida, United States
United States, Texas
San Antonio, Texas, United States
Puerto Rico
Santurce, Puerto Rico
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Layout table for additonal information Identifier: NCT00120835    
Other Study ID Numbers: NV-08A-003
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: June 10, 2010
Last Verified: June 2010
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents