Status:
COMPLETED
Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribo...
Detailed Description
Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients
Eligibility Criteria
Inclusion
- Willingness to participate
- 18 years or older, either gender, any race
- Must have Hepatitic C Virus Low Viral Load \[LCV LVL\] (positive, but \<600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction \[HCV-RNA/qPCR\] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
- Subject considered suitable for treatment per local label
- Investigator considers suitable and subject consents to be treated
Exclusion
- Does not show negative polymerase chain reaction \[PCR\] at week 4
- Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
- Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the Summary of Product Characteristics \[SmPC\]
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT00709228
Start Date
May 1 2006
End Date
November 1 2008
Last Update
January 26 2015
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