Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)
Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program.
1 other identifier
observational
601
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
May 17, 2010
CompletedOctober 6, 2015
October 1, 2015
4.1 years
June 23, 2008
April 21, 2010
October 5, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
24 or 48 weeks (depending on genotype) and 24 weeks of follow up
Average Length of Treatment With PegIntron/Rebetol
After start of treatment
Study Arms (1)
Patients with hepatitis C
Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
Interventions
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
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.
Eligibility Criteria
Adult patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.
You may qualify if:
- Adult patients with hepatitis C
You may not qualify if:
- According to the products' labeling (refer to Warnings, contraindications, and safety sections).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 25, 2008
Study Start
March 1, 2005
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
October 6, 2015
Results First Posted
May 17, 2010
Record last verified: 2015-10