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PREDICT (Part 2)- Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With HCV Genotype 1 Low Viral Load (HCV LVL 1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negative HCV-RNA At Week 4 and at Week 24
The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Status | COMPLETED |
| Enrolment | 2 |
| Start date | 2009-12 |
| Completion | 2011-06 |
Conditions
- Hepatitis C
Interventions
- Standard of Care PegIntron
- Standard of Care Ribavirin
Primary outcomes
- Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study — From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]
A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.