Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T)
ConditionAtaxia-Telangiectasia (A-T)
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
AgeNot listed
SponsorIntraBio Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
Levacetylleucine
Drug1 gram levacetylleucine as granules in unit-dose packet. Investigational drug is administered as oral suspension, up to three times per day, based on body weight.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov