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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University Health Network, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01227798
First received: October 22, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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 Intervention Phase
Influenza
Drug: Interferon alfacon-1
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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


Secondary Outcome Measures:
  • Virologic Clearance [ Time Frame: Day 1,2-4,7,10,14, (21) ] [ Designated as safety issue: No ]
    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)

  • Cytokines and PBMC [ Time Frame: Day 1,2-4,7,10,14 ] [ Designated as safety issue: No ]
    levels of pro-inflammatory cytokines in serum.

  • Clinical Improvement [ Time Frame: Duration of hospitalization ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227798

Locations
Canada, Ontario
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eric Chow, MSc    6472946510    eric.chow@uhn.on.ca   
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
Investigators
Principal Investigator: Dante Morra, MD, MBA University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dante Morra, MD, University Health Network
ClinicalTrials.gov Identifier: NCT01227798     History of Changes
Other Study ID Numbers: 2009-H1N1, 09-0599-B
Study First Received: October 22, 2010
Last Updated: October 22, 2010
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
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 July 26, 2014