NCT00704522

Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)

Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 601 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic
• Hepacivirus

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon alfa-2b (SCH 54031)	Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
DRUG	Ribavirin (SCH 18908)	Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
BEHAVIORAL	Patient assistance program	Assistance programs will be classified as follows: 1. Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications) 2. Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature). In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.

Timeline

• Start date: 2005-03-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-06-25
• Last updated: 2015-10-06
• Results posted: 2010-05-17