CClinicalTrials.gg
CompletedNCT00120861Updated Jun 10, 2010

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

A Phase 2 interventional study of valopicitabine and pegylated interferon in Chronic Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed at 11 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-06-10.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Hepatitis C

Keywords

  • Genotype-1
  • Previously failed treatment
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

Browse Hepatitis A studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All

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

Exclusion Criteria:

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

Other protocol-defined exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • Drugvalopicitabine
  • Drugpegylated interferon
  • Drugribavirin
06

Study locations

11 sites
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Miami, Florida, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • New York, New York, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00120861
Lead sponsor
Merck Sharp & Dohme LLC
First posted
Jul 19, 2005
Start date
Jan 2005
Last update
Jun 10, 2010
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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