N/A
N=496
Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00709228 ↗Enrolled (actual)
496
Serious AEs
2.3%
Results posted
Feb 2010
Primary outcome: Primary: Number of HCV LVL G1 Participants Who Relapsed — 16 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PegIntron (Drug); Rebetol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of HCV LVL G1 Participants Who Relapsed |
16 | — |
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-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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]
Data sourced from ClinicalTrials.gov (NCT00709228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.