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

This study is not yet open for participant recruitment.
Verified August 2011 by Closter Pharma
Sponsor:
Information provided by (Responsible Party):
Closter Pharma
ClinicalTrials.gov Identifier:
NCT01426204
First received: August 29, 2011
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Closter Pharma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from Gastrointestinal Practices as well as hepatologyst practice. Academic Centers have been asked to participate.

Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Closter Pharma
ClinicalTrials.gov Identifier: NCT01426204     History of Changes
Other Study ID Numbers: COL-BIO-NIS001
Study First Received: August 29, 2011
Last Updated: August 30, 2011
Health Authority: Colombia: INVIMA

Keywords provided by Closter Pharma:
Hepatitis C
Retreatment
Failures
Infergen
Interferon Alfacon-1

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Interferons
Interferon alfacon-1
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013