NCT07380165Available不适用
Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T)
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- IntraBio Inc
研究概览
简要总结
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.
详细描述
This expanded access program provides access to investigational drug, levacetylleucine, for eligible patients with Ataxia-Telangiectasia that are not eligible for other clinical trials, and a medical doctor has decided there is potential benefit outweighing the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
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