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

Hepatitis C Clinical Trial

Official title:

Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728494
• Other study ID #: P04671
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: July 20, 2015
• Start date: October 2005
• Est. completion date: December 2007

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Komisja Bioetyczna
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• According to PegIntron/Rebetol label.

• Only HCV genotype 1 infected patients will be enrolled in the study.

Exclusion Criteria:

• According to PegIntron/Rebetol label.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Biological:
• PegIntron (peginterferon alfa-2b; SCH 54031)
Peginterferon alfa-2b will be administered according to the product's labeling.

Drug:
• Rebetol (ribavirin; SCH 18908)
Ribavirin will be administered according to the product's labeling.

Behavioral:
• Patient Assistance Program
The patient assistance program includes the following: Training by physicians or specialized nurses. Informational materials based on the "To beat HCV" program. Management of specific side effects.

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	The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C	Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program	At the end of the 48-week treatment period	No
Primary	The Number of Participants With a Sustained Virologic Response 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	Measured at 6 months post-treatment	No
Primary	The Number of Participants Who Relapsed at 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	Measured at end of treatment and 6 months post-treatment	No
Secondary	Average Length of Treatment	Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.	Maximum 48-week treatment duration	No
Secondary	Average Dosage of PegIntron	Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week	Up to 48-week treatment duration	No
Secondary	Average Dosage of Rebetol	Rebetol dosage was expressed in milligrams per kilogram of body weight per day.	Up to 48-week treatment duration	No