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.
ClinicalTrials.gov 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
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 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
Genders Eligible for Study:   Both

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118768

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00118768     History of Changes
Other Study ID Numbers: NV-08A-006 
Study First Received: June 30, 2005
Last Updated: February 27, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2016