Long-term safety assessment of TAK-881 for primary immunodeficiency diseases
Long-term Safety and Tolerability of TAK-881 in Subjects With Primary Immunodeficiency Diseases (PIDD)
PHASE3 · Takeda · NCT06076642
This study is testing the long-term safety of a treatment called TAK-881 in adults and children with primary immunodeficiency diseases who have already taken part in a previous study.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Takeda (industry) |
| Locations | 5 sites (Macon, Georgia and 4 other locations) |
| Trial ID | NCT06076642 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the long-term safety and tolerability of TAK-881, an immunoglobulin treatment, in adults and children with primary immunodeficiency diseases who have previously participated in study TAK-881-3001. Participants will receive TAK-881 infusions at a dosage determined by their last dose in the previous study, with the option to adjust the dosing interval and amount based on clinical assessments. The study is divided into two epochs, where participants will be monitored for safety and antibody responses over a period of up to two years.
Who should consider this trial
Good fit: Ideal candidates are individuals who have completed study TAK-881-3001 and are willing to comply with the study protocol.
Not a fit: Patients with serious medical conditions that could affect their safety or the study's evaluation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe long-term treatment option for patients with primary immunodeficiency diseases.
How similar studies have performed: Other studies evaluating long-term safety of immunoglobulin treatments have shown promising results, suggesting that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Participants who meet ALL of the following criteria are eligible for this study: * Participant must have completed Study TAK-881-3001 (NCT05755035). * Participant/Participant's parent(s)/legal guardian(s) is/are willing and able to comply with the requirements of the protocol. * Participant/Participant's parent(s)/legal guardian(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device, prior to the initiation of any study procedures. Exclusion Criteria * Participant has a serious medical condition such that the participant'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 (NCT05755035), that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of TAK-881 and/or conduct of the study. * Participant 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 \[NCT05755035\]). * Participant is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. * Participant is a family member or employee of the investigator or the investigator's site staff. * Women of childbearing potential who meet any one of the following criteria:- 1. Participant has a positive pregnancy test. 2. Participant does not agree to employ a highly effective form of contraception for the duration of the study. * If female, participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.
Where this trial is running
Macon, Georgia and 4 other locations
- Central Georgia Infectious Disease Consultants — Macon, Georgia, United States (RECRUITING)
- Sneeze, Wheeze, & Itch Associates, LLC — Normal, Illinois, United States (RECRUITING)
- Montefiore Medical Center — Bronx, New York, United States (RECRUITING)
- Duke Asthma, Allergy and Airway Center — Durham, North Carolina, United States (RECRUITING)
- Allergy Partners of North Texas — Dallas, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Immunodeficiency Diseases