A Phase III, Extension Clinical Trial to Demonstrate Efficacy and Safety of Liposomal Cyclosprine a Via the PARI Investigational EFlow® Device and SoC in Treating Bronchiolitis Obliterans in Patients Post Single or Double Lung Transplant
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Zambon SpA
- 入组人数
- 262
- 试验地点
- 37
- 主要终点
- Mean change in FEV1 from Baseline to Week 24
研究概览
简要总结
The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
详细描述
This is a Phase III, multicenter, open-label, extension clinical trial of L-CsA for the treatment of BOS.
Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to SoC, regardless of the randomization arm in prior trials.
IMP will be administered by BID inhalation (morning/evening) using the L-CsA eFlow. Patients who did not receive L-CsA in BOSTON-1 or BOSTON-2 must remain in the clinic for at least 4 hours for observation after the first inhalation. At all subsequent visits, one dose administered via inhalation will be monitored by the clinical trial center personnel. In case patients receiving L-CsA undergo the last visit for BOSTON-1 or BOSTON-2 (Visit 9) on the same day as for Visit 1 for BOSTON-3, they will take the first dose for Boston 3 in the evening of this day. This first dose will not be supervised by the site staff. Nebulization time per inhalation dose is approximately 6-10 minutes for the 5 mg dose and 9-13 minutes for the 10 mg dose. Inhalations will be performed BID approximately 12 hours apart through a mouthpiece by slow and deep respiration using the L-CsA eFlow. A high efficiency particulate air filter is used to prevent environmental contamination during exhalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed all visits through the End of Treatment Visit in either BOSTON-1 or BOSTON-2, did not withdraw informed consent, and did not prematurely terminate study drug administration.
- •Patients should be on a three-drug maintenance regimen of immunosuppressive agents including tacrolimus or another CNI, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone.
- •Patients capable of understanding the purposes and risks of the clinical trial, who have given written informed consent and agree to comply with the clinical trial requirements/visit schedules, and who are capable of aerosol inhalation.
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to Visit 1 and must agree to use one of the methods of contraception listed in Appendix II through their End of Study Visit.
排除标准
- •Known hypersensitivity to L-CsA or to cyclosporine A.
- •Patients who experienced an AE related to study drug that led to permanent study drug discontinuation in BOSTON-1 or BOSTON-
- •Patients with new onset of malignancy while participating in BOSTON-1 or BOSTON-2, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas.
- •Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy through their End of Study Visit.
- •Women who are currently breastfeeding.
- •Receipt of an investigational drug, other than L-CsA, as part of a clinical trial within 4 weeks prior to Visit
- •This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use.
- •Patients who are currently participating in an interventional clinical trial, other than BOSTON-1 or BOSTON-
- •Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures.
- •Any co-existing medical condition that in the Investigator's judgment will substantially increase the risk associated with the patient's participation in the clinical trial.
研究组 & 干预措施
L-CsA 5 mg plus Standard of Care
L-CsA 5 mg twice daily plus Standard of Care for up to 144 weeks for patients post Single Lung Transplant
干预措施: Liposomal Cyclosporine A 5 mg (Drug)
L-CsA 10 mg plus Standard of Care
L-CsA 10 mg twice daily plus Standard of Care for up to 144 weeks for patients post Double Lung Transplant
干预措施: Liposomal Cyclosporine A 10 mg (Drug)
结局指标
主要结局
Mean change in FEV1 from Baseline to Week 24
时间窗: Baseline to Week 24
FEV1 is the Forced Expiratory Volume in One Second
次要结局
- Mean change in FEV1 from Baseline to Week 48(Baseline to Week 48)
- Mean change in FEV1/FVC from Baseline to Week 24(Baseline to Week 24)
- Mean change in FEV1/FVC from Baseline to Week 48(Baseline to Week 48)
- Time to Progression of BOS(Baseline to End of Study, approximately 2 years)
- Mean change in FEV1 from Baseline to End of Study(Baseline to end of study, approximately 2 years)