ong-term Safety and Tolerability of TAK-881 in Subjects with Primary Immunodeficiency Diseases (PIDD)

Phase 1

• Conditions: Primary Immunodeficiency Diseases; MedDRA version: 20.0Level: PTClassification code: 10064859Term: Primary immunodeficiency syndrome Class: 100000004850; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-505946-24-00
• Lead Sponsor: Takeda Development Center Americas Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-06
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Has completed Study TAK-881-3001., If female of childbearing potential, the subject presents with a negative pregnancy test at screening and agrees to employ a highly effective form of contraception for the duration of the study., Subject/legally authorized representative is willing and able to comply with the requirements of the protocol.

Exclusion Criteria

Subject has a serious medical condition such that the subject’s safety or medical care would be impacted by participation in this long-term follow-up study., New medical condition that developed during participation in Study TAK-881-3001 that, in the judgment of the investigator, could increase risk to the subject or interfere with the evaluation of TAK-881 and/or conduct of the study., Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001)., Subject is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study., Subject is a family member or employee of the investigator or the investigator’s site staff., If female, subject is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of TAK-881 in all subjects;Secondary Objective: To assess infections in all subjects., To evaluate long-term immunogenicity of TAK-881 in all subjects., To assess IgG trough levels in all subjects., To assess the treatment regimen with TAK-881 in all subjects., To evaluate infusion parameters with TAK-881 in all subjects., To assess subject satisfaction with TAK-881 treatment in subjects aged =16 years., To assess subject HRQoL while on TAK-881 treatment in subjects aged =12 years., To assess treatment preferences for subjects using TAK-881 in subjects aged =12 years., To assess HRU for subjects using TAK-881., To assess infusion preparation time for TAK-881 by nurse/pharmacist recordings in subjects aged =16 years.;Primary end point(s): Occurrence of TEAEs., Occurrence of infusion withdrawals, interruptions, and infusion rate reductions due to TAK-881-related TEAEs.