OBSERVER: Efficacy, Safety and Adherence of Patients Infected With Hepatitis C Virus in Retreat With INFERGEN (Interferon Alfacon1)

Sponsor

Closter Pharma (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01426204

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Aug 1, 2013

Outcome Measures

Primary Outcome Measures

Incidence of SVR [24 weeks post end of therapy]
•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.

Secondary Outcome Measures

Safety profile [Treatment weeks 4, 12, 24,32, 40, 48, and Follow-Up weeks 4 and 24]
•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