Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 601
- Primary Endpoint
- Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
Overview
Brief Summary
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with hepatitis C
Exclusion Criteria
- •According to the products' labeling (refer to Warnings, contraindications, and safety sections).
Arms & Interventions
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
Intervention: Peginterferon alfa-2b (SCH 54031) (Biological)
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
Intervention: Ribavirin (SCH 18908) (Drug)
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
Intervention: Patient assistance program (Behavioral)
Outcomes
Primary Outcomes
Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
Time Frame: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up
Average Length of Treatment With PegIntron/Rebetol
Time Frame: After start of treatment
Secondary Outcomes
No secondary outcomes reported