This trial is active, not recruiting.

Condition adverse effects in the therapeutic use of interferon
Treatment interferon gamma 1b
Phase phase 1
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
(Active Comparator)
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.
interferon gamma 1b Actimmune
Standard therapy vs dose titration
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
interferon gamma 1b Actimmune
Standard therapy vs dose titration

Primary Outcomes

Change in severity of FLS vs baseline
time frame: 8 hrs post injection, thru 3 weeks of treatment

Secondary Outcomes

Subject dropout rate
time frame: over 3 week study treatment

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Vidara Therapeutics Research Ltd.