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Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD

Primary Purpose

Graft-versus-host Disease (GVHD)

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Ruxolitinib
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Graft-versus-host Disease (GVHD) focused on measuring ruxolitinib, acute or chronic steroid-refractory GVHD, hematopoietic stem cell transplantation (allo-HSCT)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2022
    Last Updated
    January 26, 2023
    Sponsor
    Incyte Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05722912
    Brief Title
    Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD
    Official Title
    Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Approved for marketing
    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
    To provide ruxolitinib through an expanded access to treat a single patient with cGVHD

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Graft-versus-host Disease (GVHD)
    Keywords
    ruxolitinib, acute or chronic steroid-refractory GVHD, hematopoietic stem cell transplantation (allo-HSCT)

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ruxolitinib
    Other Intervention Name(s)
    INCB018424
    Intervention Description
    Ruxolitinib Cream

    10. Eligibility

    Sex
    All
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pooja Khandelwal, MD
    Organizational Affiliation
    Children's Hospital Medical Center, Cincinnati
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD

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