Clinical trial NCT01929382: Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers
Official title: A Randomized, Double-Blind, Crossover Study to Determine the Effect of Actimmune® Dose Titration on the Severity and Incidence of Interferon Gamma-1b-Related Flu-Like Symptoms and the Pattern of Dropouts in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Adverse Effects in the Therapeutic Use of Interferon
Keywords: dose titration
FLS
flu like symptoms
Actimmune
Lead sponsor: Vidara Therapeutics Research Ltd
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches, and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy volunteers as well as in patients.

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.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Ability to understand purpose \& risks
* BMI 18-32kg/m2
* Females on contraception

Exclusion Criteria:

* History of HIV,or pos test for HCV Ab,or HBsAg
* 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

Primary outcomes:
measure: Change in severity of FLS vs baseline
timeFrame: 8 hrs post injection, thru 3 weeks of treatment
Secondary outcomes:
measure: Subject dropout rate
timeFrame: over 3 week study treatment
Other outcomes:
measure: Change in severity of FLS vs baseline
timeFrame: At 4 & 12 hours post injection
Locations:
city: St. Paul
country: United States
facility: Prism Research Inc
state: Minnesota
Study officials:
affiliation: Prism Research Inc
name: Mark Matson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.