Overview

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

Status:
Completed
Trial end date:
2017-03-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Horizon Pharma Ireland, Ltd., Dublin Ireland
Collaborator:
Friedreich's Ataxia Research Alliance
Treatments:
Interferon-gamma
Interferons
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.