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

Closter Pharma40 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Willing to consent to data being collected 2. Considered by the investigator as an appropriate patient for treatment with INFERGEN in retreatment.

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks post end of therapy

Secondary Outcomes

Safety profile

•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

Time frame: Treatment weeks 4, 12, 24,32, 40, 48, and Follow-Up weeks 4 and 24

Data from ClinicalTrials.gov

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