Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers
This trial is active, not recruiting.
|Condition||adverse effects in the therapeutic use of interferon|
|Treatment||interferon gamma 1b|
|Sponsor||Vidara Therapeutics Research Ltd|
|Start date||July 2013|
|End date||September 2013|
|Trial size||40 participants|
|Trial identifier||NCT01929382, VTRL Clin 2013-001|
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.
|Endpoint classification||safety study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
|Primary purpose||supportive care|
Change in severity of FLS vs baseline
time frame: 8 hrs post injection, thru 3 weeks of treatment
Subject dropout rate
time frame: over 3 week study treatment
Male or female participants from 18 years up to 55 years old.
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
|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|
|Principal investigator||Mark Matson, MD|
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