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

Completed · Phase 3

Conditions studied: Friedreich's Ataxia

In brief

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).

Key facts

Study ID

NCT02797080

Run by

Amgen

People needed

38

Starts

2016-06-28

Expected to finish

2017-03-31

Last updated by the study team

2024-12-10

Who can join

Age: 11 and older, up to 27. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• If in the opinion of the Investigator, patients have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the subject at unacceptable risk, the subject will be excluded from the study.

Where it is running

• University of California, Los Angeles Neurology Clinic — Los Angeles, California, United States
• University of Florida Clinical Research Center — Gainesville, Florida, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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