N/A
Completed N=99
Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)
Hepatitis C, Chronic · Hepatitis C
Source: ClinicalTrials.gov NCT00728494 ↗
Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcomePrimary: The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C — 51; 32 Participants
Summary
Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C |
51; 32 | — |
| PRIMARY The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment |
29; 7 | — |
| PRIMARY The Number of Participants Who Relapsed at 6 Months Post-treatment |
17; 4 | — |
| SECONDARY Average Length of Treatment |
6; 5; 3; 2; 13; 9 | — |
| SECONDARY Average Dosage of PegIntron |
1.46; 1.45 | — |
| SECONDARY Average Dosage of Rebetol |
12.63; 12.01 | — |
Eligibility Criteria
Inclusion Criteria
- According to PegIntron/Rebetol label.
- Only HCV genotype 1 infected patients will be enrolled in the study.
Exclusion Criteria
- According to PegIntron/Rebetol label.
Data sourced from ClinicalTrials.gov (NCT00728494). 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.