Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)

Completed

• Conditions: Hepatitis C, Chronic; Hepatitis C
• Interventions: Biological: PegIntron (Peginterferon alfa-2b); Drug: Rebetol (Ribavirin)

• Registration Number: NCT00725205
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-10-10
• Results First Submitted QC: 2011-10-10
• Results First Posted: 2011-11-18
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

• Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin.

Read More

Exclusion Criteria

• According to Peginterferon alfa-2b/Ribavirin label.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic hepatitis C participants	Rebetol (Ribavirin)	Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study.
Chronic hepatitis C participants	PegIntron (Peginterferon alfa-2b)	Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Are Triple-80 Compliant	24 or 48 Weeks	Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received \>= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for \>=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.

Secondary Outcome Measures

Name	Time	Method
Number Of Participants Self-Administering Pegylated Interferon Alfa-2b	Up to 48 Weeks	Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.
Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up	24 Weeks following completion of 24 or 48 weeks of therapy	Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.