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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 18
- Primary Endpoint
- Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: TAK-771 (Drug)
Outcomes
Primary Outcomes
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 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.
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
Time Frame: Up to 3 years
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.
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.
Secondary Outcomes
No secondary outcomes reported