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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Closter Pharma.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426204
First Posted: August 31, 2011
Last Update Posted: August 31, 2011
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.
Information provided by (Responsible Party):
Closter Pharma
  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:


Further study details as provided by Closter Pharma:

Primary Outcome Measures:
  • 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:
  • 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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
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

Responsible Party: Closter Pharma
ClinicalTrials.gov Identifier: NCT01426204     History of Changes
Other Study ID Numbers: COL-BIO-NIS001
First Submitted: August 29, 2011
First Posted: August 31, 2011
Last Update Posted: August 31, 2011
Last Verified: August 2011

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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents