Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers
Information source: Vidara Therapeutics Research Ltd
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adverse Effects in the Therapeutic Use of Interferon
Intervention: interferon gamma 1b (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Vidara Therapeutics Research Ltd Official(s) and/or principal investigator(s):
Mark Matson, MD, Principal Investigator, Affiliation: Prism Research Inc
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.
Clinical Details
Official title: A Randomized, Double-Blind, Crossover Study to Determine the Effect of ActimmuneŽ Dose Titration on the Severity and Incidence of Interferon Gamma-1b-Related Flu-Like Symptoms and the Pattern of Dropouts in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Change in severity of FLS vs baseline
Secondary outcome: Subject dropout rate
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Prism Research Inc, St. Paul, Minnesota 55114, United States
Additional Information
Related publications: 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.
Starting date: July 2013
Last updated: August 26, 2013
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