Safety and Efficacy Study of Interferon to Treat Patients... | NCT01227798

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

NCT01227798

Sponsor

University Health Network, Toronto

Status

Unknown status

Last Update Posted

Oct 25, 2010Estimated

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Influenza

Interventions

Interferon alfacon-1
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
09-0599-B	Other Identifier	UHN Research Ethics Board

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

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Nov 2011Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Oct 22, 2010

First Submission Date that Met QC Criteria

Oct 22, 2010

First Posted Date

Oct 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2010

Last Update Posted Date

Oct 25, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Health Network, TorontoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2	Drug: Placebo
Infergen	Active Comparator	15mcg subcutaneous injection at fill volume of 0.5mL	Drug: Interferon alfacon-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon alfacon-1	Drug	15 mcg at fill volume of 0.5mL	Infergen	Infergen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Virologic Clearance	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)	Day 1,2-4,7,10,14, (21)
Cytokines and PBMC

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dante Morra, MD, MBA	University Health Network, Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network		Toronto	Ontario	M5G 2C4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human
D009976	Orthomyxoviridae Infections

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C050739	interferon alfacon-1

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided