Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

PHASE3CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 28, 2016

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
Friedreich's Ataxia
Interventions
DRUG

interferon γ-1b

ACTIMMUNE® will be administered three times per week by subcutaneous injection. The initial dose will be individualized for each participant and will be determined by the investigator, provided that the initial dose does not exceed the maximum tolerated dose in HZNP-ACT-302 (NCT02593773). The investigator may subsequently adjust the dose for any participant if deemed clinically appropriate, provided that the dose does not exceed 100 μg/m².

Trial Locations (4)

19104

Children's Hospital of Philadelphia, Philadelphia

32610

University of Florida Clinical Research Center, Gainesville

52242

University of Iowa Children's Hospital, Iowa City

90038

University of California, Los Angeles Neurology Clinic, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Friedreich's Ataxia Research Alliance

OTHER

lead

Amgen

INDUSTRY