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

This study has been completed.
Sponsor:
Information provided by:
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00120835
First received: July 11, 2005
Last updated: June 9, 2010
Last verified: June 2010
History of Changes
  Purpose

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:

Drug Information available for: Interferon
U.S. FDA Resources

Further study details as provided by Idenix Pharmaceuticals:

Study Start Date: July 2004
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00120835

Locations
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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov 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:
Genotype-1
Treatment-Naive

Additional relevant MeSH terms:
Hepatitis
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
Interferons
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 16, 2012