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 because the information has not been verified recently.
Verified August 2011 by Closter Pharma.
Recruitment status was  Not yet recruiting
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
  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 ] [ 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
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, see Learn About Clinical Studies.

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
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon alfacon-1
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014