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NCT02181257 · ClinicalTrials.gov registry record · Phase 3
Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts
A Phase 3 study of Bronchiolitis Obliterans Syndrome (BOS), sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT02181257 is a Phase 3 study of Bronchiolitis Obliterans Syndrome (BOS) that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 280 participants. The trial reports 20 study locations across 17 states.
The verdict
NCT02181257, a Phase 3 study of Bronchiolitis Obliterans Syndrome (BOS), is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Extracorporeal Photopheresis (ECP)
- OTHER No intervention in the SOC / Retrospective Chart review.
Study Locations (20)
Michigan
- University of Michigan Health System - Ann Arbor
- Spectrum Health - Grand Rapids
Pennsylvania
- Temple University - Philadelphia
- University of Pittsburgh - Pittsburgh
Texas
- Baylor University Medical Center - Dallas
- UT Southwestern Medical Center - Dallas
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
California
- University of California San Diego - La Jolla
Florida
- University of Florida - Gainesville
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2015-01 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02181257
The ClinicalTrials.gov registry entry for NCT02181257 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bronchiolitis Obliterans Syndrome (BOS) appearing as the primary indexed condition, and to 2 interventions - of which Extracorporeal Photopheresis (ECP) is the first listed.
NCT02181257 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Michigan, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT02181257 about?
NCT02181257 is a clinical study titled "Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts". 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 Febru...
What is the current status of trial NCT02181257?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2015-01. Estimated completion is 2028-12.
What conditions does trial NCT02181257 study?
This clinical trial studies the following conditions: Bronchiolitis Obliterans Syndrome (BOS).
What interventions are being tested in trial NCT02181257?
The interventions under investigation include: Extracorporeal Photopheresis (ECP) (COMBINATION_PRODUCT), No intervention in the SOC / Retrospective Chart review. (OTHER).
Who is sponsoring clinical trial NCT02181257?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02181257 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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