Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adverse Effects in the Therapeutic Use of Interferon

Intervention / Treatment
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* Drug: interferon gamma 1b


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Actimmune (interferon gamma 1b)<br>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. | Drug: interferon gamma 1b<br>* Standard therapy vs dose titration<br>* Other names: Actimmune;|
| Experimental: Actimmune(interferon gamma 1b) titration<br>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 | Drug: interferon gamma 1b<br>* Standard therapy vs dose titration<br>* Other names: Actimmune;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of FLS vs baseline |  | 8 hrs post injection, thru 3 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject dropout rate |  | over 3 week study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dose titration, FLS, flu like symptoms, Actimmune