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Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00120861
First received: July 11, 2005
Last updated: June 9, 2010
Last verified: June 2010
July 11, 2005
June 9, 2010
January 2005
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Complete list of historical versions of study NCT00120861 on ClinicalTrials.gov Archive Site
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Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy
This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: valopicitabine
  • Drug: pegylated interferon
  • Drug: ribavirin
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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 chronic hepatitis C and compensated liver disease
  • Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
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Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00120861
NV-08A-004
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Merck Sharp & Dohme Corp.
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Merck Sharp & Dohme Corp.
June 2010

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