Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)

Study Overview
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Brief Summary
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Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

Detailed Description
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Enrollment of participants will occur in a sequential order of treatment initiation.

Official Title
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Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program

Conditions
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Hepatitis C, Chronic, Hepacivirus

Intervention / Treatment
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* Biological: Peginterferon alfa-2b (PegIntron)
* Drug: Rebetol (Ribavirin)
* Behavioral: Psychotherapy support program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with hepatitis C Exclusion Criteria: According to the products' labeling

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 |
| --- | --- |
| PegIntron/Rebetol and psychotherapy support program<br>Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. | Biological: Peginterferon alfa-2b (PegIntron)<br>* Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg^kg^week<br>* Other names: ViraferonPeg;Drug: Rebetol (Ribavirin)<br>* Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day<br>* Other names: SCH 18908;Behavioral: Psychotherapy support program<br>* Each site has implemented a psychotherapy support program.<br>|
| PegIntron/Rebetol alone (no psychotherapy)<br>Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. | Biological: Peginterferon alfa-2b (PegIntron)<br>* Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg^kg^week<br>* Other names: ViraferonPeg;Drug: Rebetol (Ribavirin)<br>* Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day<br>* Other names: SCH 18908;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program. |  | 12 months after onset of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol |  | 12 months after onset of treatment |