Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505946-24-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
| Baxalta Innovations GmbH, now part of Takeda | UNKNOWN |
Not provided
Not provided
Not provided
The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035).
The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits.
Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.
The study consists of two Epochs: Epoch 1 and Epoch 2. In Epoch 1 eligible participants will have the opportunity to receive TAK-881 for a minimum of 6 months. After 6 months in study TAK-881-3002, the results of the anti-rHuPH20 binding antibody assay from either study TAK-881-3001 (NCT05755035) or study TAK-881-3002 (Epoch 1) will be used to determine the next steps in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-881 | Experimental | Epoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 using Koru 24 G HlgH Flo subcutaneous (SC) safety needle set (investigational in the US) at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002. Epoch 2: Participants with anti-rHuPH20 antibody titer >=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121. After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-881 | Biological | Participants will receive SC infusion of TAK-881. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Week 121 | |
| Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs | Up to Week 121 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of all Infections | Up to Week 121 | |
| Annualized Rate of Acute Serious Bacterial Infections (ASBIs) | Up to Week 121 | |
| Annualized Rate of Episodes of Fever |
Not provided
Inclusion Criteria
Participants who meet ALL of the following criteria are eligible for this study:
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 was enrolled 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.
Participants with potential to become pregnant who meet any one of the following criteria:-
If participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Sciences I | Irvine | California | 92697 | United States | ||
| Allergy & Asthma Clinical Research |
Not provided
| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
Not provided
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US) | Device | The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion. |
|
| Up to Week 121 |
| Time to First ASBI | Up to Week 121 |
| Duration of Infections | Up to Week 121 |
| Number of Participants With Positive Binding Antibodies and Neutralizing Antibodies to rHuPH20 | Up to Week 121 |
| Trough Level of Total IgG | Up to Week 121 |
| Doses of TAK-881 | Up to Week 121 |
| Treatment Interval of TAK-881 | Up to Week 121 |
| Number of Infusions Per Month With TAK-881 | Up to Week 121 |
| Number of Infusions Sites (Needle Sticks) per Month With TAK-881 | Up to Week 121 |
| Number of Infusions Sites (Needle Sticks) per infusion With TAK-881 | Up to Week 121 |
| Duration of Infusions (minutes) With TAK-881 | Up to Week 121 |
| Monthly Infusion Time (minutes/month) With TAK-881 | Up to Week 121 |
| Maximum Tolerated Infusion Rate per Site (milliliter/hour/site) With TAK-881 | Up to Week 121 |
| Infusion Volume per Site (milliliter/site) With TAK-881 | Up to Week 121 |
| Number of Participants who have Infusions of TAK-881 at Physical Location | Physical location includes site/infusion center or home. | Up to Week 121 |
| Number of Participants, Caregiver, or Healthcare Professional (HCP) who have Administration of TAK-881 | Up to Week 121 |
| Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores in Participants Aged >=16 Years | TSQM-9 is a 9-item, validated, self-administered instrument to assess participants satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The item scores of each of the 3 domains are summed and transformed to create a total score of 0 (extremely dissatisfied) to 100 (extremely satisfied). Higher score indicates greater satisfaction in that domain. | From Week 13 up to Week 121 |
| Health-Related Quality of Life (HRQoL): EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Score in Participants Aged >=12 Years | The EQ-5D-5L is a validated, self-administered assessment of overall health designed by the EuroQol Group. The instrument consists of two components: the EQ-5D descriptive system and the standard vertical EQ visual analogue scale (EQ-VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has five response categories: no problems, slight problems, some or moderate problems, severe problems, or extreme problems. Participants will be asked to describe their health state that day by choosing one of 5 responses that reflect the levels of severity for each of the 5 dimensions. The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health. Higher score indicates best health status. | From Baseline up to Week 121 |
| Treatment Preference Measured by a Disease-specific Questionnaire for TAK-881 in Participants Aged >=12 Years | The disease-specific treatment preference questionnaire is a self-administered, non-validated scale to assess participant preference for various attributes of IgG therapy and accompanying devices, such as ease of use of administration of TAK-881 complexity of administration, and convenience. The questionnaire consists of two components. The first component asks participants to indicate the extent to which they like or dislike aspects of TAK-881, including treatment frequency, time, ease, convenience, and complexity. Each item has five response categories: like very much, like, no preference, dislike, and dislike very much. The second component is a single question asking whether they would choose to continue receiving treatment after the trial ends. | At Weeks 25 and 73 |
| Number of Days not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or their Treatment or Other Illnesses | Up to Week 121 |
| Number of Days on Antibiotics | Up to Week 121 |
| Number of Hospitalizations With Indications (Infection or other Illnesses) | Up to Week 121 |
| Number of Days of Hospitalization | Up to Week 121 |
| Number of Acute Physician Visits Due to Infection or Other Illnesses | Up to Week 121 |
| Infusion Preparation Time For TAK-881 by HCP | Up to Week 121 |
| Infusion Preparation Time For TAK-881 by Participants/Caregiver | Up to Week 121 |
| Walnut Creek |
| California |
| 94598 |
| United States |
| National Jewish Medical And Research Center | Denver | Colorado | 80206-2761 | United States |
| University of South Florida | St. Petersburg | Florida | 33701 | United States |
| Central Georgia Infectious Disease Consultants | Macon | Georgia | 31201 | United States |
| Rush University Medical Center-Allergy/ Immunology Center | Chicago | Illinois | 60612-3852 | United States |
| Sneeze, Wheeze, & Itch Associates, LLC | Normal | Illinois | 61761 | United States |
| Louisiana State University Health Science Center | New Orleans | Louisiana | 70118 | United States |
| North Shore-Long Island Jewish Health Systems | Great Neck | New York | 11021 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Duke Asthma, Allergy and Airway Center | Durham | North Carolina | 27705 | United States |
| Allergy, Asthma and Immunology Center | Tulsa | Oklahoma | 74136 | United States |
| Allergy Partners of North Texas | Dallas | Texas | 75230 | United States |
| University Hospital Brno | Brno | 62500 | Czechia |
| Fakultni nemocnice Motol a Homolka Ustav imunologie | Prague | 150 06 | Czechia |
| Aarhus Universitetshospital | Aarhus | 8200 | Denmark |
| General Hospital of Thessaloniki | Thessaloniki | 56429 | Greece |
| Uniwersyteckie Centrum Kliniczne (UCK) | Gdansk | 80-952 | Poland |
| Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie | Lodz | 90329 | Poland |
| Wojskowy Instytut Medyczny Panstwowy Instytut | Warsaw | 04-141 | Poland |
| Instytut Pomnik - Centrum Zdrowia Dziecka | Warsaw | 04-730 | Poland |
| NUDCH (National Institute of Childrens Diseases) | Bratislava | 833 40 | Slovakia |
| OKIA s.r.o | Košice | 040 01 | Slovakia |
| Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK | Martin | 036 01 | Slovakia |
| Hospital Sant Joan de Deu Barcelona | Barcelona | 08950 | Spain |
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided