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

Hepatitis C Clinical Trial

Official title:

Patient Compliance During PegIntron (Injection Pen) and Rebetol Combination Therapy in Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725205
• Other study ID #: P04690
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: October 7, 2015
• Start date: March 2006
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• PegIntron (Peginterferon alfa-2b)
Peginterferon alfa-2b (injection pen) administered according to the product's labeling and current practice in Hungary (1.5 micrograms [mcg]/killogram [kg]) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.

Drug:
• Rebetol (Ribavirin)
Ribavirin capsules administered according to the product's labeling and current practice in Hungary (weight based daily) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Are Triple-80 Compliant	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.	24 or 48 Weeks	No
Secondary	Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up	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.	24 Weeks following completion of 24 or 48 weeks of therapy	No
Secondary	Number Of Participants Self-Administering Pegylated Interferon Alfa-2b	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.	Up to 48 Weeks	No