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Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)

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; Hepacivirus

Intervention: Peginterferon alfa-2b (SCH 54031) (Biological); Ribavirin (SCH 18908) (Drug); Patient assistance program (Behavioral)

Phase: N/A

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.


Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

Clinical Details

Official title: Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program.

Average length of treatment for patients receiving a patient assistance program as part of their treatment for hepatitis C with PegIntron plus Rebetol.


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


Inclusion Criteria:

- Patients with chronic hepatitis C naive to treatment

Exclusion Criteria:

- None

Locations and Contacts

Additional Information

Starting date: October 2004
Last updated: November 17, 2014

Page last updated: August 23, 2015

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