Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza
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
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedOctober 25, 2010
August 1, 2010
1 year
October 22, 2010
October 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of Clinically Important (moderate or severe) and serious adverse events
occurrence, severity, time to onset, duration (number of days), seriousness, nature.
Up to two-months post-treatment
Secondary Outcomes (3)
Virologic Clearance
Day 1,2-4,7,10,14, (21)
Cytokines and PBMC
Day 1,2-4,7,10,14
Clinical Improvement
Duration of hospitalization
Study Arms (2)
Placebo
PLACEBO COMPARATOR100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2
Infergen
ACTIVE COMPARATOR15mcg subcutaneous injection at fill volume of 0.5mL
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health Network
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dante Morra, MD, MBA
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 25, 2010
Study Start
November 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
October 25, 2010
Record last verified: 2010-08