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

Hepatitis C Clinical Trial

— OBSERVER  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01426204
• Other study ID #: COL-BIO-NIS001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 29, 2011
• Last updated: August 30, 2011
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2011
• Source: Closter Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Closter Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Treatment weeks 4, 12, 24,32, 40, 48, and Follow-Up weeks 4 and 24	Yes