Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease
Primary Purpose
Chronic Graft Vs. Host Disease
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
INCA34176
Sponsored by
About this trial
This is an expanded access trial for Chronic Graft Vs. Host Disease focused on measuring Chronic Graft Vs. Host Disease, cGVHD
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05544032
First Posted
September 14, 2022
Last Updated
September 15, 2023
Sponsor
Incyte Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05544032
Brief Title
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease
Official Title
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
5. Study Description
Brief Summary
Expanded access of Axatilimab to treat a single patient with Chronic Graft versus Host Disease (cGVHD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft Vs. Host Disease
Keywords
Chronic Graft Vs. Host Disease, cGVHD
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
INCA34176
Intervention Description
Treatment with axatilimab includes receiving intravenous (IV) doses of axatilimab every 4 weeks
10. Eligibility
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Hamilton, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease
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