Multicenter, Safety and Efficacy, Open-Label Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

Status: Completed

Location: See all (4) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 3

SUMMARY

The purpose of this phase 3 multi-center, open-label extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 10

Maximum Age: 26

Healthy Volunteers: f

View:

• Written informed consent and child assent, if applicable.

• Completed 26 weeks of blinded treatment in Study HZNP-ACT-301 (NCT02415127).

• If female, the subject is not pregnant or lactating or intending to become pregnant during the study, or within 30 days after the last dose of study drug. Female subjects of child-bearing potential must have a negative urine pregnancy test result at Baseline/Day 1 (Week 26 of Study HZNP-ACT-301 \[NCT02415127\]), and agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug.

Locations

United States

California

University of California, Los Angeles Neurology Clinic

Los Angeles

Florida

University of Florida - Clinical Research Center

Gainesville

Iowa

University of Iowa Children's Hospital

Iowa City

Pennsylvania