Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Immune Globulin, 10% · 6 trials · 4 indications
Total serum trough levels of IgG antibodies measured during period 2 of Epoch 2 were assessed.
Total serum trough levels of IgG antibodies measured during Epoch 3 were assessed.
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.
Relative Change is defined as 100 \* (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.
Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.
Acute serious bacterial infections will include bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess, diagnosed according to the Diagnostic Criteria for Serious Acute Bacterial Infections
Expressed as (AUC\_SC/AUC\_IV) \* 100
Administration of IGIV, 10%: - Part 1 = IV administration (IV) - Parts 2, 3a, 3b = SC administration (SC)
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs
| Arm | Type | Description |
|---|---|---|
| Epoch 1: IGIV 200-600 mg/kg | EXPERIMENTAL | Participants received 200 to 600 mg/kg of Immunoglobulin Intravenous (IGIV) infusion for every 3 or 4 weeks for up to 13 weeks. |
| Epoch 2: IGSC (20%) 50-200 mg/kg | EXPERIMENTAL | Participants who entered to Epoch 2 from Epoch 1 received 50-200 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion once a week up to approximately 24 weeks after Epoch 1. |
| Epoch 3: IGSC (20%) 100-400 mg/kg | EXPERIMENTAL | Participants who entered to Epoch 3 from Epoch 1 received 100-400 mg/kg of Immune Globulin Subcutaneous (Human) 20% infusion biweekly up to approximately 12 weeks after Epoch 2. |
| IGIV, 10% Then Placebo | EXPERIMENTAL | STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: IGIV, 10% (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg body weight (BW) per infusion cycle). |
| Placebo Then IGIV, 10% | EXPERIMENTAL | STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human) (Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: IGIV, 10% (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle) |
| Study Epochs 1-4 | EXPERIMENTAL | Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. |
| Epoch 1 (intravenous pre-study treatment) + Epoch 2 | EXPERIMENTAL | Study Epoch 1 (13 weeks): treatment with KIOVIG (once every 3 or 4 weeks, dose as during pre-study period) + Study Epoch 2 (same for all subjects, 51 weeks): treatment with IGSC, 20% (every week, dose to be calculated on the basis of weekly equivalents) |
| Epoch 1 (subcutaneous pre-study treatment) + Epoch 2 | EXPERIMENTAL | Study Epoch 1 (12 weeks): treatment with SUBCUVIA (once every week or once every two weeks, dose as during pre-study period) + Study Epoch 2 (same for all subjects, 51 weeks): treatment with IGSC, 20% (every week, dose to be calculated on the basis of weekly equivalents) |
| Name | Type | Description |
|---|---|---|
| Immune Globulin Intravenous (IGIV) | BIOLOGICAL | Participants will receive IGIV infusion. |
| Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%) | BIOLOGICAL | Participants will receive IGSC, 20% SC infusion. |
| Immune Globulin Intravenous (human), 10% | BIOLOGICAL | Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific) |
| 0.25% human albumin solution (Placebo) | BIOLOGICAL | Cross-over Period 1 (Randomized) / Cross-over Period 2 (opposite of the treatment received in Cross-over Period 1); Dose: Same volume/frequency as Stabilization Phase 1 |
| Immune Globulin Intravenous (Human), 10% Solution | BIOLOGICAL | Intravenous infusion with IGIV, 10% |
| Immune Globulin Subcutaneous (Human), 20% Solution | DRUG | Subcutaneous infusion with IGSC, 20% |
| Immune Globulin Subcutaneous (Human), 20% | BIOLOGICAL | Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects) |
| Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin) | BIOLOGICAL | Subcutaneous infusion (regulated via a pump) |
Inclusion Criteria: * Be of Japanese descent, defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents. * Participants must have a documented diagnosis of a form of primary humoral immunodeficiency involving antibody formation and requiring gammaglobulin ...
Immune Globulin, 10% is used for Primary Immunodeficiency Diseases (PID) and Multifocal Motor Neuropathy. It is an investigational therapy being developed by Takeda Pharmaceutical Company Limited. The drug is currently in Phase 3 clinical development for these indications.
Immune Globulin, 10% is a monoclonal antibody therapy. It works by providing passive immunity through the administration of immunoglobulins, which help the body fight infections and modulate immune responses. This mechanism is relevant for treating Primary Immunodeficiency Diseases and Multifocal Motor Neuropathy.
Immune Globulin, 10% is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for Primary Immunodeficiency Diseases and Multifocal Motor Neuropathy.
Immune Globulin, 10% is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, NCT00666263, evaluated its effectiveness for Multifocal Motor Neuropathy and has been completed.
Immune Globulin, 10% has been studied in several completed trials. These include NCT00546871 for Primary Immunodeficiency Diseases, NCT00666263 for Multifocal Motor Neuropathy, and NCT01218438 and NCT01412385 for Primary Immunodeficiency Diseases. All trials have been completed, with no active trials currently ongoing.
Immune Globulin, 10% and IGSC, 20% are different formulations. While both are immune globulin products, they have different concentrations and routes of administration. The clinical trials for Immune Globulin, 10% include studies on intravenous administration, whereas IGSC, 20% is a subcutaneous formulation.