N/A
Completed N=2
Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)
Source: ClinicalTrials.gov NCT01054742 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study — 0; 2; 2; 2 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study |
0; 2; 2; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Willingness to participate
- 18 years or older, either gender, any race
- Participant has relapsed at the end of the Part 1 follow-up phase (defined as having a positive virology result at 24 weeks of follow-up post treatment after a negative result at the Week 24 end-of-treatment time point)
- Participant considered suitable for treatment per local label
- Investigator considers suitable and participant consents to be treated
Exclusion Criteria
- Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
- Participant does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the SmPC
Data sourced from ClinicalTrials.gov (NCT01054742). 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. Informational only — not medical advice.