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Cytokine

Actimmune(interferon gamma 1b) titration for Adverse Effects of Interferon Therapy (FLS Trial)

Phase 1
Waitlist Available
Led By Mark Matson, MD
Research Sponsored by Vidara Therapeutics Research Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 & 12 hours post injection
Awards & highlights

FLS Trial 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.

FLS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 & 12 hours post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 & 12 hours post injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Subject dropout rate
Other outcome measures
Change in severity of FLS vs baseline

FLS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Actimmune(interferon gamma 1b) titrationExperimental Treatment1 Intervention
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
Group II: Actimmune (interferon gamma 1b)Active Control1 Intervention
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vidara Therapeutics Research LtdLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Mark Matson, MDPrincipal InvestigatorPrism Research Inc
7 Previous Clinical Trials
332 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers
2013. "Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01929382.
All > Health > Flu
~3 spots leftby Apr 2025
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