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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
Incyte Corporation
About
Eligibility
Locations
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    September 15, 2023
    Sponsor
    Incyte Corporation
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    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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