Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic; Hepatitis C
Intervention: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological); Rebetol (ribavirin; SCH 18908) (Drug); Patient Assistance Program (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
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.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis CThe Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment The Number of Participants Who Relapsed at 6 Months Post-treatment
Secondary outcome: Average Length of TreatmentAverage Dosage of PegIntron Average Dosage of Rebetol
Detailed description:
Non-Probability Sample, Commercial product used according to EU label.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: October 2005
Last updated: July 20, 2015
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