STEADFAST Long-Term Safety Extension

ClinicalTrials.gov. First received: June 2, 2016. ClinicalTrials.gov Identifier: NCT02797080. Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland.
Official Title: Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

 Phase 3

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.

 STEADFAST Long-Term Safety Extension