Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 26, 2005
Last updated: April 25, 2016
Last verified: April 2016
This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.

Condition Intervention Phase
Chronic Hepatitis C
Drug: val-mCyd
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase I/II Double-Blind, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Val-mCyd (NM283) in Adults With Chronic Hepatitis C

Resource links provided by NLM:

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

Study Start Date: February 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Documented clinical history of chronic hepatitis C and compensated liver disease
  • No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with HBV 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: NCT00227435

United States, California
Pasadena, California, United States
United States, Massachusetts
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Virginia
Fairfax, Virginia, United States
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00227435     History of Changes
Other Study ID Numbers: NV-08A-001 
Study First Received: September 26, 2005
Last Updated: April 25, 2016
Health Authority: United States: Food and Drug Administration

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 processed this record on May 26, 2016