MedDataX Logo

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

NCT ID: NCT01227798

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal Saline

Infergen

15mcg subcutaneous injection at fill volume of 0.5mL

Group Type ACTIVE_COMPARATOR

Interferon alfacon-1

Intervention Type DRUG

15 mcg at fill volume of 0.5mL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interferon alfacon-1

15 mcg at fill volume of 0.5mL

Intervention Type DRUG

Placebo

Normal Saline

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Infergen NS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Health Network

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dante Morra, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eric Chow, MSc

Role: primary

[email protected]
6472946510

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09-0599-B

Identifier Type: OTHER

Identifier Source: secondary_id

2009-H1N1

Identifier Type: -

Identifier Source: org_study_id