Trials / Terminated
TerminatedNCT06664853
Open-Label Extension of EryDex Study IEDAT-04-2022
An Open-Label Extension Study of EryDex in Patients With Ataxia Telangiectasia Following Participation in Study IEDAT-04-2022 (NEAT)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Quince Therapeutics S.p.A. · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
The IEDAT-05-2024 study aims to provide EryDex (dexamethasone sodium phosphate encapsulated into autologous erythrocytes) treatment to patients who complete the full study treatment period (including those receiving placebo) in the IEDAT-04-2022 (NEAT) study, who complete the study assessments, do not present safety contraindications to continuation of treatment, and provide informed consent. The open-label extension (OLE) treatment period will be 12 months. Participants will be considered to have completed the study when Visit 14 (Safety Follow-up) has been performed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone sodium phosphate | Dexamethasone Sodium Phosphate encapsulated in autologous erythrocytes and administered via intravenous (IV) infusion |
Timeline
- Start date
- 2024-12-11
- Primary completion
- 2026-01-30
- Completion
- 2026-01-30
- First posted
- 2024-10-30
- Last updated
- 2026-02-27
Locations
21 sites across 9 countries: United States, Denmark, Germany, Italy, Norway, Poland, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06664853. Inclusion in this directory is not an endorsement.