Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 115
- Primary Endpoint
- Proportion of patients who complete treatment with PegIntron plus 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 and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. 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
- •Patients with chronic hepatitis C naive to treatment
Exclusion Criteria
- Not provided
Arms & Interventions
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C will be enrolled into this study. All patients will receive PegIntron plus Rebetol (according to the label) and the patient assistance program.
Intervention: Peginterferon alfa-2b (SCH 54031) (Biological)
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C will be enrolled into this study. All patients will receive PegIntron plus Rebetol (according to the label) and the patient assistance program.
Intervention: Ribavirin (SCH 18908) (Drug)
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C will be enrolled into this study. All patients will receive PegIntron plus Rebetol (according to the label) and the patient assistance program.
Intervention: Patient assistance program (Behavioral)
Outcomes
Primary Outcomes
Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program.
Time Frame: NA (i.e. the study was terminated)
Average length of treatment for patients receiving a patient assistance program as part of their treatment for hepatitis C with PegIntron plus Rebetol.
Time Frame: NA (i.e. the study was terminated)
Secondary Outcomes
No secondary outcomes reported