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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 Clearance

Cytokines 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

Page last updated: August 23, 2015

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