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Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)

NCT00704522 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 601

Last updated 2015-10-06

Study results available
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Summary

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. 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.

Conditions

  • Hepatitis C, Chronic
  • Hepacivirus

Interventions

BIOLOGICAL

Peginterferon alfa-2b (SCH 54031)

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

DRUG

Ribavirin (SCH 18908)

Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.

BEHAVIORAL

Patient assistance program

Assistance programs will be classified as follows: 1. Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications) 2. Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature). In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2009-04-30
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704522 on ClinicalTrials.gov