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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01426204

Acronym

OBSERVER

Enrollment

Registered

2011-08-31

Start date

2011-09-30

Completion date

2013-08-31

Last updated

2011-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C, Retreatment, Failures, Infergen, Interferon Alfacon-1

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results