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Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts

NCT02181257 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-04-06

No results posted yet for this 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

  • Bronchiolitis Obliterans Syndrome (BOS)

Interventions

COMBINATION_PRODUCT

Extracorporeal Photopheresis (ECP)

Procedure: ECP treatments will be performed using one of two Therakos systems. Both systems use the drug Methoxsalen

OTHER

No intervention in the SOC / Retrospective Chart review.

SOC Retrospective chart review similar to a control group

Sponsors & Collaborators

  • Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

    collaborator FED

  • Therakos, Inc

    collaborator UNKNOWN

  • The Foundation for Barnes-Jewish Hospital

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • George J. Despotis, M.D. · Washington University St. Louis School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2027-04-30
Completion
2028-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181257 on ClinicalTrials.gov