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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01929382

Acronym

FLS

Enrollment

Registered

2013-08-27

Start date

2013-07-31

Completion date

2013-12-31

Last updated

2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effects in the Therapeutic Use of Interferon

Keywords

dose titration, FLS, flu like symptoms, Actimmune

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.

Interventions

DRUGinterferon gamma 1b

Standard therapy vs dose titration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Subject dropout rate	over 3 week study treatment

Other

Measure	Time frame
Change in severity of FLS vs baseline	At 4 & 12 hours post injection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026