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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426204
Recruitment Status : Unknown
Verified August 2011 by Closter Pharma.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2011
Last Update Posted : August 31, 2011
Information provided by (Responsible Party):
Closter Pharma

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
Hepatitis C

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : September 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of SVR [ Time Frame: 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 :
  1. Safety profile [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Responsible Party: Closter Pharma Identifier: NCT01426204     History of Changes
Other Study ID Numbers: COL-BIO-NIS001
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: August 31, 2011
Last Verified: August 2011

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon alfacon-1
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents