N/A
N=294
Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)
Hepatitis C, Chronic · Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00725205 ↗Enrolled (actual)
294
Serious AEs
3.1%
Results posted
Nov 2011
Primary outcome: Primary: Number of Participants Who Are Triple-80 Compliant — 183 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PegIntron (Peginterferon alfa-2b) (Biological); Rebetol (Ribavirin) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Triple-80 Compliant |
183 | — |
| SECONDARY Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up |
66 | — |
| SECONDARY Number Of Participants Self-Administering Pegylated Interferon Alfa-2b |
291 | — |
Summary
Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.
Eligibility Criteria
Inclusion Criteria
- Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin.
Exclusion Criteria
- According to Peginterferon alfa-2b/Ribavirin label.
Data sourced from ClinicalTrials.gov (NCT00725205). 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.