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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.


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 C

The 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 Treatment

Average Dosage of PegIntron

Average Dosage of Rebetol

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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