Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Bronchiolitis Obliterans Syndrome (BOS), sponsored by Washington University School of Medicine.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparing the average rate of FEV1 (from pulmonary function test (PFT) or spirometry) decline over the 6 months prior to ECP against the average rate of FEV1 decline over the 12 months following initiation of ECP. A clinical response will be defined as a 50% or greater reduction in the rate of decline of FEV1 before and after the ECP treatment.
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 |
What the registry record for NCT02181257 still lists
NCT02181257 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02181257's enrollment target sits among peer trials
280 1196th of 2000 higher than 802 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04084730 · 280 participants · Phase 2
Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
- NCT04518657 · 280 participants · NA
Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
- NCT04634916 · 280 participants · NA
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
- NCT04829617 · 280 participants · NA
Promoting Well-being and Health in Heart Failure
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia