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Completed

NCT Number: NCT05513586

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

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.

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Key information

Conditions

Primary Immunodeficiency Diseases (PID) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340).
  • 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.
  • Participant is willing and able to comply with the requirements of the protocol.

Exclusion criteria

  • 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.
  • Participant is willing to participate in other clinical trials.
  • Women of childbearing potential who meet any one of the following criteria:
  • Participant presents with a positive pregnancy test.
  • 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.

Treatment and study plan

TAK-771

Drug

Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)

Other names: Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Primary outcomes

  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From start of study drug administration up to end of study (up to 3.1 years)

    An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including a clinically significant laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not causality is suspected. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product.

  2. Percentage of Participants Who Developed Anti-rHuPH20 Binding Antibody Titers of >=1:160 and Neutralizing Antibodies to rHuPH20

    Time frame: From start of study drug administration up to end of study (up to 3.1 years)

    Participants who developed anti-rHuPH20 binding antibody titers of >=1:160 and neutralizing antibodies to rHuPH20 was reported.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2022
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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