Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers
NCT ID: NCT01929382
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2013-07-31
2013-12-31
Brief Summary
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This study is designed to determine whether a titration of dosing reduces the frequency and severity of the FLS. A reported study with another interferon (interferon beta), demonstrated a reduction in the frequency and severity of the FLS when a titration of dosing was used. This study will compare the effects of the standard dose regimen with a titration regimen in healthy volunteers.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Actimmune (interferon gamma 1b)
Subjects \> 0.5m2 BSA will receive 50 mcg/m2 BSA and subjects ≤ 0.5m2 BSA will receive 1.5mcg/kg/dose, as SC injections three times weekly, from week 1 to week 3.
interferon gamma 1b
Standard therapy vs dose titration
Actimmune(interferon gamma 1b) titration
30% of the recommended dose as SC injections three times weekly in week 1, 60% the recommended dose as SC injections three times weekly in week 2, and at the recommended dose as SC injections three times weekly in week 3
interferon gamma 1b
Standard therapy vs dose titration
Interventions
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interferon gamma 1b
Standard therapy vs dose titration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to understand purpose \& risks
* BMI 18-32kg/m2
* Females on contraception
Exclusion Criteria
* History of chronic fatigue syndrome or fibromyalgia
* Flu like illness within 1 month of start
* History of depression or other mood disorder
* History of malignant or pre-malignant disease
* History of severe allergic reactions
* Known allergy to Actimmune or its components
* History of major diseases
* Clinically Significant abnormal labs
* Pregnant or breastfeeding
* Clinically abnormal ECG
* History of alcohol or substance abuse
* Other study participation in last 4 weeks
* Serious infection within 3 months
* Use of Rx products within 4 weeks except contraceptives or dermatology products
* Vaccinations within 2 weeks
* Tobacco products ( with limitations)
* Cant/wont comply with study requirements
* Allergy shots within 1 month
* Blood donation with limitations
* Investigator discretion as to unsuitability
18 Years
55 Years
ALL
Yes
Sponsors
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Vidara Therapeutics Research Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Matson, MD
Role: PRINCIPAL_INVESTIGATOR
Prism Research Inc
Locations
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Prism Research Inc
Saint Paul, Minnesota, United States
Countries
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References
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Matson MA, Zimmerman TR Jr, Tuccillo D, Tang Y, Deykin A. Dose titration of intramuscular interferon beta-1a reduces the severity and incidence of flu-like symptoms during treatment initiation. Curr Med Res Opin. 2011 Dec;27(12):2271-8. doi: 10.1185/03007995.2011.630720. Epub 2011 Oct 28.
Devane JG, Martin ML, Matson MA. A short 2 week dose titration regimen reduces the severity of flu-like symptoms with initial interferon gamma-1b treatment. Curr Med Res Opin. 2014 Jun;30(6):1179-87. doi: 10.1185/03007995.2014.899209. Epub 2014 Mar 13.
Other Identifiers
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VTRL Clin 2013-001
Identifier Type: -
Identifier Source: org_study_id