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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2041220059 | Registry Identifier | jRCT |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-771 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-771 | Drug | Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | From start of study drug administration up to end of study (up to 3.1 years) |
| Percentage of Participants Who Developed Anti-rHuPH20 Binding Antibody Titers of >=1:160 and Neutralizing Antibodies to rHuPH20 | Participants who developed anti-rHuPH20 binding antibody titers of >=1:160 and neutralizing antibodies to rHuPH20 was reported. | From start of study drug administration up to end of study (up to 3.1 years) |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | Japan | |||
| Hospital of University of Occupational and Environmental Health |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
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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.
Participants who completed the study TAK-771-3004 (NCT05150340) were enrolled in this extension study and continued to receive TAK-771.
A total of 15 participants with primary immunodeficiency diseases (PID) took part in the study in Japan from 13 Sep 2022 to 30 Oct 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-771 | Participants continued TAK-771 (Immune Globulin Infusion [IGI] 10% + Recombinant Human Hyaluronidase [rHuPH20]) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received subcutaneous (SC) infusion of rHuPH20 solution first at a dose of 80 units per gram (U/g), followed by SC infusion of 10 percentage (%) IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target immunoglobulin G (IgG) trough level of greater than or equal to (>=) 5 gram per litre (g/L). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set for Extension Study (EXSAS) included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-771 | Participants continued TAK-771 (IGI 10% + rHuPH20) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received SC infusion of rHuPH20 solution first at a dose of 80 U/g, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target IgG trough level of >=5 g/L. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once. | Posted | Number | percentage of participants | From start of study drug administration up to end of study (up to 3.1 years) |
|
From start of study drug administration up to end of study (up to 3.1 years)
EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-771 | Participants continued TAK-771 (IGI 10% + rHuPH20) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received SC infusion of rHuPH20 solution first at a dose of 80 U/g, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target IgG trough level of >=5 g/L. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2022 | Apr 21, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2024 | May 17, 2026 | SAP_001.pdf |
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| 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 |
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| Kitakyushu |
| Fukuoka |
| Japan |
| Kanagawa Children's Medical Center | Yokohama | Kanagawa | Japan |
| Tokyo Medical Dental University Hospital | Bunkyo-ku | Tokyo | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Gifu University Hospital | Gifu | Japan |
| Hiroshima University Hospital | Hiroshima | Japan |
| Saitama Prefectual Children's Medical Center | Saitama | Japan |
| Shizuoka Childrens Hospital | Shizuoka | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| TAK-771 |
Participants continued TAK-771 (IGI 10% + rHuPH20) administration at the same dose and frequency they had in the Study TAK-771-3004 (NCT05150340) with dosing intervals of either 3 or 4 weeks, until the commercial TAK-771 becomes available at each study site or study termination. Participants received SC infusion of rHuPH20 solution first at a dose of 80 U/g, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of TAK-771 was adjusted to maintain the target IgG trough level of >=5 g/L. |
|
|
| Primary | Percentage of Participants Who Developed Anti-rHuPH20 Binding Antibody Titers of >=1:160 and Neutralizing Antibodies to rHuPH20 | Participants who developed anti-rHuPH20 binding antibody titers of >=1:160 and neutralizing antibodies to rHuPH20 was reported. | EXSAS included all enrolled participants who received investigational drug in Study TAK-771-3005 at least once. | Posted | Number | percentage of participants | From start of study drug administration up to end of study (up to 3.1 years) |
|
|
|
| 0 |
| 15 |
| 6 |
| 15 |
| 15 |
| 15 |
| COVID-19 | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Eyelid ptosis | Eye disorders | MedDRA 28.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
|
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Administration site erythema | General disorders | MedDRA 28.1 | Systematic Assessment |
|
| Administration site pruritus | General disorders | MedDRA 28.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 28.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Autoimmune thyroiditis | Endocrine disorders | MedDRA 28.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA 28.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 28.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
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| Gastric polyps | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.1 | Systematic Assessment |
|
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Infusion site swelling | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 28.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 28.1 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
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| Keratitis interstitial | Eye disorders | MedDRA 28.1 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Liver function test increased | Investigations | MedDRA 28.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 28.1 | Systematic Assessment |
|
| Oedema genital | Reproductive system and breast disorders | MedDRA 28.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 28.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 28.1 | Systematic Assessment |
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| Sensory disturbance | Nervous system disorders | MedDRA 28.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 28.1 | Systematic Assessment |
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| Tinea versicolour | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 28.1 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 28.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 28.1 | Systematic Assessment |
|
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