Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for Primary Immunodeficiency Diseases (PID). It is an investigational monoclonal antibody being developed by Takeda Pharmaceutical Company Limited (TAK). The drug is currently in Phase 2 clinical development for this indication.
Immune Globulin Infusion, 10% is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug for the treatment of Primary Immunodeficiency Diseases (PID).
Immune Globulin Infusion, 10% is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for Primary Immunodeficiency Diseases (PID) in a completed Phase 2 trial.
Immune Globulin Infusion, 10% has one completed clinical trial, NCT01485796, titled 'Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD'. This Phase 2 trial enrolled 54 participants with Primary Immunodeficiency Diseases (PID) in the United States.
Yes, Immune Globulin Infusion, 10% is also referred to as IGI, 10% in clinical trial documentation. The Phase 2 trial NCT01485796 uses the abbreviation IGI, 10% in its title, referring to the same investigational drug for Primary Immunodeficiency Diseases.