Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study

Completed · Phase 3

Conditions studied: Friedreich's Ataxia

In brief

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.

Key facts

Study ID

NCT02593773

Run by

Amgen

People needed

86

Starts

2015-12-25

Expected to finish

2017-03-21

Last updated by the study team

2024-12-19

Who can join

Age: 10 and older, up to 26. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the study protocol or have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the subject at unacceptable risk.
• NOTE: Additional inclusion/exclusion criteria may apply.

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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