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Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts

Study acronym: ECP
StatusActive, Not Recruiting
PhasePhase 3
Started2015-01
View on ClinicalTrials.gov ↗
The primary aims of this study is to determine the efficacy and tolerability of Extracorporeal Photopheresis (ECP) for the treatment of either Refractory Bronchiolitis Obliterans Syndrome (BOS) patients (258 at cessation of enrollment April 7, 2022) or Newly Diagnosed (22 as of enrollment Hold February 2022) Bronchiolitis Obliterans Syndrome patients after lung transplantation. In compliance with the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) decision, the study will collect specified demographic, comorbidity, treatment, and outcome data exclusively for Medicare beneficiaries who are treated with ECP for either refractory or New BOS.

Amendment record

Amended 27 times since 2014-07-01; most recent filed 2026-03-31. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2026-03-31
Amendment Study Status, Contacts/Locations v27
2025-04-14
Amendment Study Status, Sponsor/Collaborators v26
2024-07-12
Amendment Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures v25
2024-01-11
Amendment Study Status v24
2023-06-27
Amendment Study Status v23
2023-01-31
Amendment Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Eligibility v22
2022-06-20
Amendment Study Status v21
2022-04-11
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v20
2021-07-09
Amendment Study Status, Contacts/Locations v19
2021-04-21
Amendment Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v18
2020-08-24
Amendment Study Status, Contacts/Locations v17
2020-02-20
Amendment Study Status, Contacts/Locations v16
2019-11-13
Amendment Study Status, Contacts/Locations v15
2019-10-31
Amendment Study Status, Contacts/Locations v14
2019-09-20
Amendment Study Status, Eligibility v13
2019-08-27
Amendment Study Status, Contacts/Locations v12
2019-06-10
Amendment Study Status, Contacts/Locations v11
2019-05-20
Amendment Study Status, Contacts/Locations v10
2019-02-27
Amendment Active, Not Recruiting→Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v9
2017-12-15
Amendment Study Status v8
2017-10-04
Amendment Study Status v7
2016-11-22
Amendment Recruiting→Active, Not Recruiting Study Status, Sponsor/Collaborators, Contacts/Locations v6
2016-02-04
Amendment Study Status, Contacts/Locations v5
2015-12-21
Amendment Study Status, Contacts/Locations v4
2015-11-09
Amendment Study Status, Contacts/Locations v3
2015-07-21
Amendment Study Status, Contacts/Locations v2
2015-02-01
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2014-07-01
Original filing
Trial Details
NCT Number NCT02181257
Lead Sponsor Washington University School of Medicine
Collaborators: Centers for Medicare and Medicaid Services/ Coverage and Analysis Group, Therakos, Inc, The Foundation for Barnes-Jewish Hospital
Conditions Bronchiolitis Obliterans Syndrome (BOS)
Enrollment 280 participants
Start Date 2015-01
Primary Completion 2027-04 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-06