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Also known as Recombinant human hyaluronidase
Recombinant human hyaluronidase+ immune globulin · 2 trials · 1 indication
Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen. VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only. The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Efficacy and tolerability of subcutaneous (SC) infusions of immune globulin intravenous (IGIV), 10% with hyaluronidase (rHuPH20) after ramp-up |
| 2 | EXPERIMENTAL | Pharmacokinetics of intravenous (IV) infusions of immune globulin intravenous (IGIV), 10% and efficacy and tolerability of subcutaneous (SC) infusions of immune globulin intravenous (IGIV), 10% with hyaluronidase (rHuPH20) after ramp-up |
| Name | Type | Description |
|---|---|---|
| Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV) | BIOLOGICAL | Comprises subjects previously participating in Study 160601, who now only complete Study Epoch 2 (subcutaneous \[SC\] infusions) as bioavailability/exposure for intravenous (IV) treatment was already obtained in Study 160601. Study Epoch 2: Dose (calculated) of rHuPH20 followed by dose (calculated) of IGIV, 10% by SC infusion. Treatment intervals and doses are to be increased as defined, until treatment interval is the same as the pre-study treatment interval for IV treatment (ramp-up). |
| Recombinant human hyaluronidase + immune globulin intravenous | BIOLOGICAL | Dose (calculated) of rHuPH20 followed by subcutaneous infusion of IGIV, 10% to determine tolerability: doses of rHuPH20 and IGIV, 10% to be increased, as tolerated and as per protocol, until a full 4-week IgG dose can be administered |
Inclusion Criteria: * Participant is 2 years or older at the time of screening * Written informed consent obtained from either the participant or the participant's legally acceptable representative prior to any study-related procedures and study product administration * Participant has been diagnos...
Recombinant human hyaluronidase + immune globulin is used for primary immunodeficiency diseases (PID). It combines immune globulin intravenous with recombinant human hyaluronidase to allow subcutaneous administration of a full immunoglobulin dose in patients with PID. It is being developed by Takeda Pharmaceutical Company Limited and is in Phase 3 development.
Recombinant human hyaluronidase + immune globulin targets F9, an exogenous protein. The recombinant human hyaluronidase component acts on hyaluronan in the subcutaneous tissue to increase permeability, enabling the immune globulin portion to be delivered subcutaneously. The immune globulin provides passive immunity for patients with primary immunodeficiency diseases.
Recombinant human hyaluronidase + immune globulin is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company responsible for the clinical development of this combination therapy for primary immunodeficiency diseases.
Recombinant human hyaluronidase + immune globulin is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Two clinical trials have been completed, and no trials are currently active. The Phase 3 trial evaluated the combination in patients with primary immunodeficiency diseases.
Recombinant human hyaluronidase + immune globulin has been studied in two completed clinical trials. NCT00814320 was a Phase 3 trial titled Gammagard Liquid and rHuPH20 in PID, enrolling 89 patients in the United States and Canada. NCT00782106 was a Phase 1 dose-determination study enrolling 11 patients in the United States.
Recombinant human hyaluronidase + immune globulin is also known as recombinant human hyaluronidase + immune globulin intravenous, recombinant human hyaluronidase, and recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV). These names refer to the same combination product being developed by Takeda for primary immunodeficiency diseases.