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AMG 714 Expanded Access Program

Primary Purpose

Celiac Disease

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
AMG 714
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Celiac Disease focused on measuring Refractory Celiac Disease Type II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2018
    Last Updated
    December 21, 2022
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03439475
    Brief Title
    AMG 714 Expanded Access Program
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    December 2022
    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
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    Expanded access requests for AMG 714 may be considered for adult patients with biopsy proven Refractory Celiac Disease Type II who have failed all available treatment options and do not have EATL. To request access, use Responsible Party contact information provided in this record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Celiac Disease
    Keywords
    Refractory Celiac Disease Type II

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    AMG 714

    10. Eligibility

    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: - Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amgen Call Center
    Phone
    866-572-6436
    Email
    medinfo@amgen.com

    12. IPD Sharing Statement

    Learn more about this trial

    AMG 714 Expanded Access Program

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