Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)
OBSERVER
1 other identifier
observational
40
0 countries
N/A
Brief Summary
This is a Phase 4, descriptive, observational, open, prospective study of patients who their doctor prescribes INFERGEN for clinical practice. No medication was provided by the sponsor. The planned observation time is 48 weeks and 24 weeks of follow-up. Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2011
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
First Submitted
Initial submission to the registry
August 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 31, 2011
August 1, 2011
9 months
August 29, 2011
August 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of SVR
•Determine the incidence of SVR, defined as undetectable HCV RNA measured 24 weeks after therapy ends, associated with prescribed, therapy with Infergen® (Interferon alfacon 1) in patients chronically infected with HCV, in retreatment.
24 weeks post end of therapy
Secondary Outcomes (1)
Safety profile
Treatment weeks 4, 12, 24,32, 40, 48, and Follow-Up weeks 4 and 24
Eligibility Criteria
Patients from Gastrointestinal Practices as well as hepatologyst practice. Academic Centers have been asked to participate.
You may qualify if:
- Willing to consent to data being collected
- Considered by the investigator as an appropriate patient for treatment with INFERGEN in retreatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Closter Pharmalead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2011
First Posted
August 31, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2012
Study Completion
August 1, 2013
Last Updated
August 31, 2011
Record last verified: 2011-08