AVAILABLENot Applicable

Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T)

Plain-language summary

This expanded access program provides investigational levacetylleucine to patients with Ataxia-Telangiectasia who are not eligible for clinical trials and have no satisfactory alternative therapies.

Who can participate

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Inclusion criteria

✓. Patient has a genetically confirmed diagnosis of Ataxia-Telangiectasia, a rare and serious disease with no alternative approved treatments.
✓. Patient and/or their legal representative signed a written informed consent and, if applicable, written assent.
✓. Patient weighs ≥15 kg.
✓. If female and of reproductive potential, the treating physician verified the patient is not pregnant prior to enrollment and will use adequate contraceptive methods to avoid pregnancy during and up to 7 days after participating in the program.
✓. Patient resides in the United States at time of enrollment and throughout the duration of their participation in the EAP.

Exclusion criteria

✕. Patient is enrolled in or early withdrew participation from a clinical trial with levacetylleucine for A-T.
✕. Patient is pregnant, breastfeeding, or considering pregnancy.
✕. Patient has a physical, cognitive, psychiatric condition, or an active or suspected malignancy that, in the judgment of the treating physician, may pose a safety risk or interfere with the patient's ability to comply with the EAP procedures.
✕. Patient is receiving N-acetyl-DL-leucine or N-acetyl-D-leucine and is unwilling to stop use throughout the duration of their participation in the EAP.
✕. Patient is receiving another investigational drug for any reason.

Trial details

NCT IDNCT07380165

SponsorIntraBio Inc

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Contact for this trial

IntraBio Medical Affairs

1-833-306-9677 medinfo@intrabio.com

View on ClinicalTrials.gov More Ataxia-Telangiectasia (A-T) trials