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Also known as Immune Globulin Infusion (Human), 10%
Immune Globulin Infusion, 10% · 1 trial · 1 indication
A point estimate and 95% confidence interval for the rate of related systemic adverse events per infusion was derived using a Poisson model.
| Arm | Type | Description |
|---|---|---|
| Epoch 1 and Epoch 2 | EXPERIMENTAL | In Study Epoch 1 PIDD patients that are already on intravenous treatment or subcutaneous treatment will be enrolled and treated with IGI, 10% and rHuPH20 subcutaneously, with a short dose/interval ramp-up (Epoch 1) consisting of one 1-week dose and interval and one 2-week dose and interval. The ramp-up (Epoch 1) is followed by Epoch 2 which consists of approximately 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated intravenously (IV), this treatment will occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated subcutaneously (SC), treatment will also occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. |
| Name | Type | Description |
|---|---|---|
| Immune Globulin Infusion (Human), 10% | BIOLOGICAL | Subcutaneous administration will be used in Study Epochs 1 and 2. |
| Recombinant human hyaluronidase | BIOLOGICAL | rHuPH20 will be administered subcutaneously (SC) immediately before each SC IGI, 10% infusion, through the same needle, at a rate of 1 to 2 mL/min. |
Inclusion Criteria: * Subject must have a documented diagnosis of a form of primary humoral immunodeficiency involving a defect in antibody formation and requiring gammaglobulin replacement, as defined according to the IUIS Scientific Committee 2009 and by diagnostic criteria according to Conley et...
Immune Globulin Infusion, 10% is an investigational biologic developed by Takeda Pharmaceutical Company Limited for Primary Immunodeficiency Diseases (PID). It is a monoclonal antibody being studied in clinical development. It is also known as Immune Globulin Infusion (Human), 10%.
Immune Globulin Infusion, 10% is being studied for the treatment of Primary Immunodeficiency Diseases (PID), a group of disorders in which the immune system does not function properly. The clinical program has focused on evaluating this therapy in patients with PID, including pediatric patients as young as 2 years old.
Immune Globulin Infusion, 10% is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor responsible for the clinical development of this investigational therapy for Primary Immunodeficiency Diseases.
Immune Globulin Infusion, 10% is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA for Primary Immunodeficiency Diseases. The Phase 2 program has been completed, and no active trials are currently listed for this asset.
Immune Globulin Infusion, 10% has been evaluated in one completed Phase 2 trial, NCT01485796, titled Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD. The study enrolled 54 participants in the United States, included patients aged 2 years and older, and was an uncontrolled, non-randomized study.
Yes, Immune Globulin Infusion (Human), 10% is an alternative name for Immune Globulin Infusion, 10%. Both names refer to the same investigational product developed by Takeda Pharmaceutical Company Limited for Primary Immunodeficiency Diseases, so readers searching under either name are looking at the same asset.