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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis C, Chronic, Hepacivirus

Intervention / Treatment
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* Biological: Peginterferon alfa-2b (SCH 54031)
* Drug: Ribavirin (SCH 18908)
* Behavioral: Patient assistance program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic hepatitis C naive to treatment Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hepatitis C<br>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. | Biological: Peginterferon alfa-2b (SCH 54031)<br>* Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.<br>* Other names: PegIntron;Drug: Ribavirin (SCH 18908)<br>* Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.<br>* Other names: Rebetol;Behavioral: Patient assistance program<br>* Patient assistance programs will be classified as follows: medications, including psychiatric medications (antidepressants); other interventions, including nurse telephone calls and nurse support in the office: and 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program. |  | 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. |  | NA (i.e. the study was terminated) |