Clincosm LogoSign in Get a demo

A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants

Sponsor
Takeda (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05513586
Collaborator
(none)
10
Enrollment
1
Arm
32.2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The main aim of the study is to check side effect from the study treatment with TAK-771 in long term.

Participants can have taken part in the previous study TAK-771-3004 (NCT05150340). For those who can take part, the participants will receive injections of TAK-771 after the end of the previous study. The participants will be treated with TAK-771 for totally 3 years.

There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-label, Non-controlled, Extension Study to Evaluate the Long-term Safety of TAK-771 in Japanese Patients With Primary Immunodeficiency Disease (PID)
Anticipated Study Start Date :
Aug 24, 2022
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAK-771

TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution.

Drug: TAK-771
Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)
Other Names:
  • Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) [Up to 3 years]

      TEAEs are defined as AEs with onset after date-time of first dose of investigational drug or medical conditions present prior to the start of investigational drug but increased in severity or relationship after date-time of first dose of investigational drug.

    2. Percentage of Participants who Develop Anti-rHuPH20 Binding Antibody Titers of Greater Than or Equal to 1:160 and who Develop Neutralizing Antibodies to rHuPH20 [Up to 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340).

    2. Written and/or electronic informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration. If a participant is <18 years of age, written and/or electronic informed consent should also be obtained from the participant's legally authorized representative in addition to written informed assent by a participant if appropriate.

    3. Participant is willing and able to comply with the requirements of the protocol.

    Exclusion Criteria:

    1. Participant has developed a new serious medical condition during Study TAK-771-3004 such that the participant's safety or medical care would be impacted by participation in the study.

    2. Participant is willing to participate in other clinical trials.

    3. Women of childbearing potential who meet any one of the following criteria:

    4. Participant presents with a positive pregnancy test.

    5. Participant does not agree to employ adequate birth-control measures (eg, intrauterine device, condom [for male partner], or birth-control pills) throughout the course of the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT05513586
    Other Study ID Numbers:
    • TAK-771-3005
    First Posted:
    Aug 24, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Primary Immunodeficiency Diseases
    Immunologic Deficiency Syndromes
    Immunoglobulins

    Study Results

    No Results Posted as of Aug 24, 2022