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

NCT ID: NCT00723879

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-07-31

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.

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 will be enrolled into this study. All patients will receive PegIntron plus Rebetol (according to the label) and the patient assistance program.

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

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.

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

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PegIntron; Rebetol

Eligibility Criteria

Inclusion Criteria

• Patients with chronic hepatitis C naive to treatment

Exclusion Criteria

• None

• 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

P04206

Identifier Type: -

Identifier Source: org_study_id