Long-Term Safety 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 long term extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia (FA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 27
Healthy Volunteers: f
View:
• Written informed consent and child assent, if applicable.
• Completed 26 weeks of treatment and the Week 28 Follow-Up visit in Study HZNP-ACT-302 (NCT02593773).
• 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 Week 26 of Study HZNP-ACT-302 (NCT02593773) 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
Children's Hospital of Philadelphia
Philadelphia
Time Frame
Start Date: 2016-06-28
Completion Date: 2017-03-31
Participants
Target number of participants: 38
Treatments
Experimental: interferon γ-1b
ACTIMMUNE® will be administered 3 times per week (TIW) by subcutaneous (SC) injection.
Authors
Related Therapeutic Areas
Sponsors
Leads: Amgen
Collaborators: Friedreich's Ataxia Research Alliance