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

This study has been completed.
Information provided by:
Idenix Pharmaceuticals 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 Idenix Pharmaceuticals:

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
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
Idenix Pharmaceuticals
  More Information

Additional Information:
No publications provided 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 Idenix Pharmaceuticals:

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents processed this record on April 17, 2014