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

NCT ID: NCT00704522

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 601 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-04-30

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.

Conditions

Hepatitis C, Chronic; Hepacivirus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with hepatitis C

Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.

Peginterferon alfa-2b (SCH 54031)

Intervention Type: BIOLOGICAL

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Ribavirin (SCH 18908)

Intervention Type: DRUG

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Patient assistance program

Intervention Type: BEHAVIORAL

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.

Interventions

Peginterferon alfa-2b (SCH 54031)

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Intervention Type: BIOLOGICAL

Ribavirin (SCH 18908)

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PegIntron, PegIntron pen; Rebetol

Eligibility Criteria

Inclusion Criteria

• Adult patients with hepatitis C

Exclusion Criteria

• According to the products' labeling (refer to Warnings, contraindications, and safety sections).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04281

Identifier Type: -

Identifier Source: org_study_id