Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: July 11, 2005
Last updated: June 9, 2010
Last verified: June 2010
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 Intervention Phase
Chronic Hepatitis C
Drug: valopicitabine
Drug: pegylated interferon
Phase 1
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: 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

Resource links provided by NLM:

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

Study Start Date: July 2004

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both

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.

  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 identifier: NCT00120835

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.
  More Information

Additional Information: Identifier: NCT00120835     History of Changes
Other Study ID Numbers: NV-08A-003 
Study First Received: July 11, 2005
Last Updated: June 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:

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
Pharmacologic Actions
Therapeutic Uses processed this record on April 27, 2016