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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

614 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-05-31

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.

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Detailed Description

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

Conditions

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Hepatitis C, Chronic Hepacivirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PegIntron/Rebetol and psychotherapy support program

Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.

Peginterferon alfa-2b (PegIntron)

Intervention Type BIOLOGICAL

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

Rebetol (Ribavirin)

Intervention Type DRUG

Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg\^day

Psychotherapy support program

Intervention Type BEHAVIORAL

Each site has implemented a psychotherapy support program.

PegIntron/Rebetol alone (no psychotherapy)

Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.

Peginterferon alfa-2b (PegIntron)

Intervention Type BIOLOGICAL

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

Rebetol (Ribavirin)

Intervention Type DRUG

Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg\^day

Interventions

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Peginterferon alfa-2b (PegIntron)

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

Intervention Type BIOLOGICAL