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Expanded Access for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Participants Aged 2 to Less Than (<) 12 Years

Sponsor
Shire (Industry)
Overall Status
Available
CT.gov ID
NCT04583007
Collaborator
Takeda Development Center Americas, Inc. (Industry)
15
Locations

Study Details

Study Description

Brief Summary

The primary purpose of this expanded access program is to evaluate clinical benefit, safety of lanadelumab in pediatric participants in the United States (US) with acute attacks of HAE who have completed the SHP643-301 (NCT04070326 [SPRING study]).

Condition or Disease Intervention/Treatment Phase

Detailed Description

This expanded access program enables the pediatric participants with a high unmet medical need to continue receiving lanadelumab during the interim period between completion of the SHP643-301 (NCT04070326 [SPRING study]) and Food and Drug Administration (FDA) review and potential approval in the age group (2 to <12 years) has been granted and when the product is commercially approved for this age group .

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Program: Lanadelumab for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Patients 2 to <12 Years of Age

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 11 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Pediatric participants, 2 to <12 years of age, with HAE who completed the SHP643-301 (SPRING) study and are deriving continued clinical benefit from lanadelumab treatment will be invited to take part in this program

    • Participants have no suitable alternative treatment options and cannot enter a lanadelumab clinical trial

    • Participant has a parent(s)/legal guardian who is informed of the nature of the expanded access program and can provide written informed consent for the child to participate (with assent from child when appropriate) prior to treatment

    • Participants does not have any of the following liver function test abnormalities : alanine aminotransferase (ALT) greater than (>)3x upper limit of normal (ULN), or aspartate aminotransferase (AST) >3x ULN, or total bilirubin >2x ULN (unless the bilirubin elevation is a result of Gilbert's syndrome)

    • Participant does not have any condition that in the opinion of the Investigator may compromise their safety

    • Participant does not have a known hypersensitivity to lanadelumab or its components

    • Participant (greater than or equal to >or=6 years) and/or caregiver is willing to self-administer lanadelumab at home and has received documented training on self-administration during the SHP643-301 (SPRING) Study

    • For Female participants of childbearing potential only:

    1. Participant has agreed to be abstinent or agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 70 days after completion ii) Participant is not pregnant or breast-feeding

    Note: Participants who does not satisfy the above criteria will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AIRE Medical of Los Angeles Santa Monica California United States 90404
    2 Allergy & Asthma Clinical Research Walnut Creek California United States 94598
    3 Institute Asthma and Allergy Chevy Chase Maryland United States 20815
    4 Hudson-Essex Allergy Belleville New Jersey United States 07109
    5 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    6 Clinical Research Center of Charlotte Charlotte North Carolina United States 28277
    7 Bernstein Clinical Research Center Cincinnati Ohio United States 45231
    8 Toledo Institute of Clinical Research Asthma & Allergy Center Toledo Ohio United States 43617
    9 AARA Research Center Dallas Texas United States 75231
    10 Yang Medicine Ottawa Ontario Canada K1G6C6
    11 Charité - Universitätsmedizin Berlin. Berlin Germany 10117
    12 Klinikum der Johann-Wolfgang Goethe-Universitat. Frankfurt Germany 60590
    13 Hämophilie Zentrum Rhein Main GmbH Moerfelden-Walldorf Germany 64546
    14 Semmelweis Egyetem. Budapest Hungary 1125
    15 Hospital Universitario La Paz. Paseo de la Castellana Madrid Spain 28046

    Sponsors and Collaborators

    • Shire
    • Takeda Development Center Americas, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT04583007
    Other Study ID Numbers:
    • TAK-743-6001
    First Posted:
    Oct 12, 2020
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Angioedema
    Angioedemas, Hereditary

    Study Results

    No Results Posted as of Oct 22, 2021