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

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: June 30, 2005
Last updated: February 27, 2009
Last verified: February 2009
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 Intervention Phase
Chronic Hepatitis C Drug: valopicitabine Drug: Pegylated Interferon Alfa 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 the Combination of Pegylated Interferon Alfa Plus NM283 (Valopicitabine) in Treatment-Naive Patients With Chronic Hepatitis C

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Estimated Enrollment: 175
Study Start Date: August 2005

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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00118768

  Show 19 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

Additional Information: Identifier: NCT00118768     History of Changes
Other Study ID Numbers: NV-08A-006
Study First Received: June 30, 2005
Last Updated: February 27, 2009

Keywords provided by Merck Sharp & Dohme Corp.:
Genotype-1, Chronic Hepatitis C

Additional relevant MeSH terms:
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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017