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

Phase 1

• Conditions: Adverse Effects in the Therapeutic Use of Interferon
• Interventions: Drug: interferon gamma 1b

• Registration Number: NCT01929382
• Lead Sponsor: Vidara Therapeutics Research Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Status Verified: 2013-08
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Last Update Submitted: 2013-08-26
• Study First Posted: 2013-08-27
• Last Update Posted: 2013-08-28
• Primary Completion: 2013-09
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Actimmune(interferon gamma 1b) titration	interferon gamma 1b	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
Actimmune (interferon gamma 1b)	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.

Primary Outcome Measures

Name	Time	Method
Change in severity of FLS vs baseline	8 hrs post injection, thru 3 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Subject dropout rate	over 3 week study treatment

Trial Locations

Locations (1)

Prism Research Inc; 🇺🇸 St. Paul, Minnesota, United States