ISRCTN10615985进行中（未招募）2 期
Extracorporeal photopheresis in the treatment of chronic lung allograft dysfunction: a randomised controlled trial
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2022年11月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38724453/ (added 10/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults (=16 years of age) with body weight =30 kg
- •2. Bilateral lung or heart and (bilateral) lung transplant recipients
- •3. Confirmed diagnosis of CLAD stages 1, 2 or 3 as per ISHLT 2019 consensus definition
- •4. New CLAD diagnosis or prior diagnosis with evidence of current progressive disease
- •5. Exclusion of non-CLAD causes for decline in lung function by high-resolution computed tomography (HRCT) thorax and bronchoscopy +/- transbronchial biopsy within 12 weeks of first CLAD diagnoses
- •6. Adequate treatment of potential non-CLAD causes of a decline in lung function (e.g. acute cellular or acute humoral rejection, infections, airway anastomotic strictures and medical treatment for gastroesophageal reflux)
- •7. =3 recorded FEV1 and FVC measurements including home spirometry obtained at intervals of =3 weeks during the 26 weeks preceding randomisation
- •8. Progressive decline in FEV1 (=10%) while on azithromycin for =6 weeks
- •9. Capacity to provide written informed consent
排除标准
- •1. Single lung transplant recipients
- •2. Female patients who are breastfeeding, pregnant or planning to become pregnant during the timeframe of study participation
- •3. Current treatment with or past history of TLI completed within the last 12 months
- •4. =1-month wash-out from any other investigational therapies for CLAD
- •5. Inability to perform lung function tests or adhere to study protocol as judged by supervising clinician
- •6. History of Hematopoietic Stem Cell Transplantation (HSCT)
- •7. Patients who are on a retransplant waiting list
- •8. Current participation in another interventional clinical trial, or participation in a clinical trial of an investigational agent in the previous 4 weeks from consent
- •9. Patients with inadequate vascular access options to perform ECP
- •10. Any contraindication to receiving ECP. These include:
- •10.1. Previous allergic reaction to Methoxsalen, another psoralen compound, or any of the other UVADEX® ingredients
- •10.2. Co-existing untreated skin cancer (melanoma, basal cell or squamous cell cancer) if the patient deemed at higher risk of harm due to exposure to UVADEX or from their CLAD diagnosis
- •10.3. Any disease which involves sensitivity to light such as porphyria, systemic lupus erythematosus or albinism
- •10.4. Previous removal of spleen
- •10.5. Blood clotting disorder or an increased white blood cell count >25 x 10e9 per litre
- •10.6. Significant heart disease or severe anaemia causing inability to tolerate blood volume shifts associated with ECP
- •10.7. Aphakia or lens removed from either eye (unless already blind in eye without a lens)
- •10.8. Sexually active men and women of childbearing potential unless adequate contraception is used during treatment
研究者
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