Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)

Terminated

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

• Registration Number: NCT00705107
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Results First Submitted: 2009-02-11
• Results First Submitted QC: 2009-04-08
• Results First Posted: 2009-06-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• Treatment-naïve patients with hepatitis C
• Patients treated with PegIntron pen and Rebetol
• Patients receiving patient assistance program

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Exclusion Criteria

• Not applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Treated Patients	PegIntron pen (peginterferon alfa-2b; SCH 54031)	All patients participating in the study
All Treated Patients	Rebetol (ribavirin; SCH 18908)	All patients participating in the study

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Completed Treatment.	Assessed at the end of the 48-week treatment.

Secondary Outcome Measures

Name	Time	Method
Average Length of Treatment.	Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.