NCT05095116No Longer Available不适用
APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis
Ellodi Pharmaceuticals, LP35 个研究点 分布在 1 个国家开始时间: 2021年10月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 35
研究概览
简要总结
This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.
详细描述
Patients will receive a 120-day supply of APT-1011 and will attend scheduled clinic visits every 4 months. Telephone visits will be performed as needed. At each clinic visit (or additional telephone visit), adverse events (AEs) and concomitant medications will be collected. The Global EoE score will be collected at clinic visits.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥12 years of age at the time of informed consent
- •Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents
- •Confirmed medical history of EoE
- •Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options
- •Willing and able to adhere to the treatment regimen and visit schedule
排除标准
- •Have known contraindication, hypersensitivity, or intolerance to corticosteroids
- •Have signs and symptoms of adrenal suppression or hypercorticism
- •Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited
- •Have current alcohol or drug abuse in the opinion of the Investigator
- •Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program
- •Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program
研究者
研究点 (35)
Loading locations...
相似试验
No Longer Available
不适用
An Expanded Access Protocol for Sebelipase Alfa for Patients With Lysosomal Acid Lipase DeficiencyLysosomal Acid Lipase DeficiencyNCT02376751Alexion Pharmaceuticals, Inc.
No Longer Available
不适用
Individual Patient Expanded Access for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage TherapeuticNCT03395743Armata Pharmaceuticals, Inc.
Approved For Marketing
不适用
An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)Bardet-Biedl Syndrome (BBS)ObesityNCT05183802Rhythm Pharmaceuticals, Inc.
No Longer Available
不适用
Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage TherapeuticNCT03395769Armata Pharmaceuticals, Inc.
Approved For Marketing
不适用
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer RefractoryMetastatic Breast CancerNCT01240421Eisai Inc.