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Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza

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: NCT01227798
Recruitment Status : Unknown
Verified August 2010 by University Health Network, Toronto.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Information provided by:
University Health Network, Toronto

Brief Summary:

A Pilot Study to Evaluate the Safety and Efficacy of interferon-Alfacon1 (INFERGEN) in the treatment of patients hospitalized with Influenza-like illness caused by a novel swine origin Influenza virus and other circulating Influenza Viruses.

The use of Interferon-alfacon1 as a co-treatment along with the standard of care antiviral is hypothesized to be safe. Clinical improvement of patients is hypothesized to be quicker.

Condition or disease Intervention/treatment Phase
Influenza Drug: Interferon alfacon-1 Drug: Placebo Phase 1 Phase 2

Detailed Description:

The purpose of this study is to see if using a medication called INFERGEN, can help get rid of the virus and/or can help the immune response to prevent the illness from getting worse in the lungs. We hope that INFERGEN will either prevent patients from getting worse and requiring intensive care or will decrease the time for which they will need intensive care.

The Interferon-alpha (also called Interferon-alphacon1 or IFN-alphacon1 or INFERGEN) is an immune molecule, which has been shown to work against different viruses (anti-viral). Interferon is the standard of treatment for patients with chronic (infection that has been there for a long time) hepatitis C (a virus which affects the liver over many years) by giving it for 6-12 months. It has also been used for a shorter time of up to 14 days, in a small study for patients with respiratory disease caused by SARS and seemed to help these patients get better more rapidly. It also has been shown to stop different Influenza viruses from growing in test tubes and in lung tissue. It has also been shown to decrease the immune response to prevent it from over-reacting to viruses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Safety and Efficacy of IFN-alfacon1 (INFERGEN) in the Treatment of Hospitalized Patients Presenting With Influenza-like Illnesses Due to the Pandemic 2009 Swine Origin Influenza A Virus (S-OIV) H1N1 and Other Circulating Influenza Viruses
Study Start Date : November 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Placebo Comparator: Placebo
100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2
Drug: Placebo
Normal Saline
Other Name: NS

Active Comparator: Infergen
15mcg subcutaneous injection at fill volume of 0.5mL
Drug: Interferon alfacon-1
15 mcg at fill volume of 0.5mL
Other Name: Infergen

Primary Outcome Measures :
  1. Frequency of Clinically Important (moderate or severe) and serious adverse events [ Time Frame: Up to two-months post-treatment ]
    occurrence, severity, time to onset, duration (number of days), seriousness, nature.

Secondary Outcome Measures :
  1. Virologic Clearance [ Time Frame: Day 1,2-4,7,10,14, (21) ]
    Clearance and/or reduction in copies/mL of viral RNA as determined by PCR and/or quantitative real-time PCR in respiratory secretions (nasopharyngeal swab, throat swab, sputum, ETT aspirate BAL)

  2. Cytokines and PBMC [ Time Frame: Day 1,2-4,7,10,14 ]
    levels of pro-inflammatory cytokines in serum.

  3. Clinical Improvement [ Time Frame: Duration of hospitalization ]

    SOFA, LIS scores at baseline, 48hrs, 96hrs, day7. Days to defervesce, days of O2 requirement, days of cough, days hospitalized, days in ICU, days with ventilatory support, days on PEEP >10cm H2O.

    Death all causes 28 days, Death all causes duration of study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Able to provide informed consent
  • Aged >=18 and < 70
  • Hospitalized
  • suspect, probable, confirmed influenza A
  • symptom onset <8 days
  • able to attend all scheduled visits

Exclusion Criteria:

  • known hypersensitivity to interferon preparation
  • pregnancy
  • chronic liver disease
  • moderate to severe congestive heart failure, grade III or IV left ventricular function
  • previous history of serious psychiatric illness
  • history of severe or active autoimmune disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01227798

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Canada, Ontario
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eric Chow, MSc    6472946510   
Principal Investigator: Dante Morra, MD, MBA         
Sub-Investigator: Eleanor Fish, PhD         
Sub-Investigator: Susy Hota, PhD         
Sub-Investigator: Conrad Liles, MD         
Sub-Investigator: Margaret Herridge, MD, MPH         
Sub-Investigator: Valerie Sales, MD, MS         
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Dante Morra, MD, MBA University Health Network, Toronto

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Responsible Party: Dante Morra, MD, University Health Network Identifier: NCT01227798     History of Changes
Other Study ID Numbers: 2009-H1N1
09-0599-B ( Other Identifier: UHN Research Ethics Board )
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: August 2010

Keywords provided by University Health Network, Toronto:
influenza A, H1N1

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Interferon alfacon-1
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents