Open-Label Extension of EryDex Study IEDAT-04-2022

About

Brief Summary

This is an international, multi-center, prospective, open-label, non-comparative study to provide EryDex treatment to ataxia telangiectasia (A-T) patients who complete the IEDAT-04-2022 trial on the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

6 Years

Maximum Age

N/A

Inclusion Criteria:

body weight ≥15 kg
participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments

Exclusion Criteria:

safety contraindications for continuation of treatment, as determined by the investigator
clinically significant immune impairment that, in the opinion of the Investigator, precludes further treatment with corticosteroids
Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years.
requiring treatment with a systemic corticosteroid

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