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
Qualifiers
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
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov