NCT00723879

Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 115 (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 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.

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	Patient assistance programs will be classified as follows: 1. medications, including psychiatric medications (antidepressants); 2. other interventions, including nurse telephone calls and nurse support in the office: and 3. educational literature about hepatitis C containing information about the disease, mode of transmission, complications, and treatment and treatment drawbacks that will be given to each patient at the start of treatment.

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-07-29
• Last updated: 2015-11-03