Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

Completed

• Conditions: Hepatitis C, Chronic; Hepatitis C
• Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908); Behavioral: Patient Assistance Program

• Registration Number: NCT00728494
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Detailed Description

Non-Probability Sample, Commercial product used according to EU label.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-05
• Results First Submitted: 2008-12-05
• Results First Submitted QC: 2009-07-07
• Results First Posted: 2009-08-19
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• According to PegIntron/Rebetol label.
• Only HCV genotype 1 infected patients will be enrolled in the study.

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Exclusion Criteria

• According to PegIntron/Rebetol label.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Alone	Rebetol (ribavirin; SCH 18908)	PegIntron/Rebetol treatment only.
Treatment and Patient Assistance Program	Rebetol (ribavirin; SCH 18908)	Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
Treatment Alone	PegIntron (peginterferon alfa-2b; SCH 54031)	PegIntron/Rebetol treatment only.
Treatment and Patient Assistance Program	PegIntron (peginterferon alfa-2b; SCH 54031)	Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
Treatment and Patient Assistance Program	Patient Assistance Program	Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.

Primary Outcome Measures

Name	Time	Method
The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C	At the end of the 48-week treatment period	Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program
The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment	Measured at 6 months post-treatment	Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment
The Number of Participants Who Relapsed at 6 Months Post-treatment	Measured at end of treatment and 6 months post-treatment	Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment

Secondary Outcome Measures

Name	Time	Method
Average Length of Treatment	Maximum 48-week treatment duration	Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.
Average Dosage of PegIntron	Up to 48-week treatment duration	Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week
Average Dosage of Rebetol	Up to 48-week treatment duration	Rebetol dosage was expressed in milligrams per kilogram of body weight per day.