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Individual Patient Expanded Access IND for Selexipag (Uptravi) in Participants With Non-healing Wound, Buerger's Disease

Primary Purpose

Non-healing Wound, Thromboangiitis Obliterans

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Selexipag
Sponsored by
Actelion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Non-healing Wound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 31, 2021
    Last Updated
    August 8, 2023
    Sponsor
    Actelion
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04914247
    Brief Title
    Individual Patient Expanded Access IND for Selexipag (Uptravi) in Participants With Non-healing Wound, Buerger's Disease
    Official Title
    Individual Patient Expanded Access IND for Selexipag (Uptravi) in Participants With Non-healing Wound, Buerger's Disease
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 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
    Actelion

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this expanded access program (EAP) is to provide Selexipag (Uptravi) for the treatment of participant with non-healing wound, buerger's disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-healing Wound, Thromboangiitis Obliterans

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Selexipag

    10. Eligibility

    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Contact
    Phone
    1-800-JANSSEN (1-800-526-7736)
    Email
    Janssenmedinfo@its.jnj.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Actelion Clinical Trial
    Organizational Affiliation
    Actelion
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Individual Patient Expanded Access IND for Selexipag (Uptravi) in Participants With Non-healing Wound, Buerger's Disease

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