Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1) (OBSERVER)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
- Incidence of SVR [ Time Frame: 24 weeks post end of therapy ] [ Designated as safety issue: No ]•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.
- Safety profile [ Time Frame: Treatment weeks 4, 12, 24,32, 40, 48, and Follow-Up weeks 4 and 24 ] [ Designated as safety issue: Yes ]•Capture of defined adverse events (AEs),dose changes or cessation, and adherence to the prescribed dose of Infergen and other prescribed therapies over the course of treatment
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|