Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)
Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C
1 other identifier
observational
267
0 countries
N/A
Brief Summary
Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2004
Typical duration 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
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 25, 2008
CompletedResults Posted
Study results publicly available
June 2, 2009
CompletedJune 30, 2015
June 1, 2015
3 years
June 23, 2008
February 11, 2009
June 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Who Completed Treatment.
Assessed at the end of the 48-week treatment.
Secondary Outcomes (1)
Average Length of Treatment.
Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.
Study Arms (1)
All Treated Patients
All patients participating in the study
Interventions
PegIntron administered in accordance with approved labeling.
Rebetol administered in accordance with approved labeling
Eligibility Criteria
Treatment-naïve adult patients with hepatitis C treated with PegIntron pen and Rebetol receiving a patient assistance program at approximately 40 sites in Romania. Patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
You may qualify if:
- Treatment-naïve patients with hepatitis C
- Patients treated with PegIntron pen and Rebetol
- Patients receiving patient assistance program
You may not qualify if:
- Not applicable
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
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 25, 2008
Study Start
November 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
June 30, 2015
Results First Posted
June 2, 2009
Record last verified: 2015-06