Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Interferon alfacon-1 (Drug); Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Not yet recruiting
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s): Dante Morra, MD, MBA, Principal Investigator, Affiliation: University Health Network, Toronto
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Frequency of Clinically Important (moderate or severe) and serious adverse events
Secondary outcome: Virologic ClearanceCytokines and PBMC Clinical Improvement
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
University Health Network, Toronto, Ontario M5G 2C4, Canada; Not yet recruiting Eric Chow, MSc, Phone: 6472946510, Email: eric.chow@uhn.on.ca Dante Morra, MD, MBA, Principal 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, Sub-Investigator
Additional Information
Starting date: November 2010
Last updated: October 22, 2010
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