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

July 11, 2005
June 9, 2010
July 2004
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Complete list of historical versions of study NCT00120835 on ClinicalTrials.gov Archive Site
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Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
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

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.

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Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: valopicitabine
  • Drug: pegylated interferon
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00120835
NV-08A-003
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Idenix Pharmaceuticals
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Idenix Pharmaceuticals
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP