Primary Immunodeficiency Disease
Conditions
Interventions
IGSC, 20%
Participants who completed Epoch 2 of core study TAK-664-3001 (NCT04346108), received between 50 to 200 mg/kg of Immune globulin subcutaneous (IGSC) infusion, 20% infusion once a week (Epoch
Sponsors
Nishizawa Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant has completed or is about to complete Takeda Clinical Study TAK-664-3001. A participant is considered to have completed Study TAK-664-3001 successfully if they fulfill the following criterion: Completed Epoch 2, in which IGSC, 20% is administered weekly (completion of Epoch 3, in which IGSC, 20% is administered biweekly, is not mandatory for participation in TAK-664-3002 study). 2. Written informed consent is obtained from either the Participant or the Participant's legally authorized representative prior to any study-related procedures and study product administration. 3. Participant is willing and able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Participant has developed a new serious medical condition during participation in Study TAK-664-3001 such that the Participant's safety or medical care would be impacted by participation in the extension study TAK-664-3002. 2. Participant is scheduled to participate in another non-Takeda clinical study involving an Investigational Product or device-used-in-clinical-trial in the course of this study. 3. If a female of childbearing potential, Participant is pregnant or has a negative pregnancy test but does not agree to employ adequate birth control measures for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of Participants with Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs Time Frame: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin [IGIV] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. 2.Number of Participants With Drug-related and Non-related TEAEs Time Frame: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose TEAEs were defined as adverse events (AEs) with onset after date-time of first dose of study drug (intravenous immunoglobulin [IGIV] or IGSC), or medical conditions present prior to the start of study drug (IGIV or IGSC) but increased in severity or relationship after date-time of first dose of study drug (IGIV or IGSC). Any TEAE that was recorded by the investigator as "probably related" or "possibly related" to study drug was considered as study drug related AE, and any AE recorded as "unlikely related" or "not related" was considered as unrelated AE. 3.Number of Participants With Severe, Local and Systemic TEAEs Time Frame: From the first dose of the study drug in the current extension study TAK-664-3002, up to 3 years post-dose A severe TEAE was an AE that caused considerable interference with the participant's usual activities. Local TEAEs were defined as AEs that were included in the MedDRA Higher Level Group Term "administration site reactions" or contained the phrase | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Serum Trough Levels of Total Immune Globulin G (IgG) and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Weekly Administration of IGSC, 20% Timeframe: At end of treatment in the current extension study TAK-664-3002 (i.e. 3 years) Serum trough levels of total IgG and IgG1, IgG2, IgG3, IgG4 antibodies subclasses were determined by using standard assay methods. 2.Serum Trough Levels of IgG and IgG1, IgG2, IgG3, IgG4 Antibodies Subclasses Following Biweekly Administration of IGSC, 20% Timeframe: At end of treatment in the current extension study TAK-664-3002 (i.e. 3 years) Serum trough levels of IgG and IgG1, IgG2, IgG3, IgG4 antibodies subclasses were determined by using standard assay methods. 3.Annual Rate of Validated Acute Serious Bacterial Infections (ASBI) Time Frame: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) The ASBI rate was calculated as the mean number of acute serious bacterial infections per participants per year. Annual rate of validated acute serious bacterial infections per participant was assessed. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measure was collected from first dose of core study to end of current extension study and the data is presented for participants who entered in current study from core study as per plan. 4.Annual Rate of All Infections Time Frame: From first dose of study drug in core study TAK-664-3001 up to end of current extension study TAK-664-3002 (up to approximately 4.5 years) The annual rate of infections was calculated as the mean number of infections per participant per year. Reported timeframe included timeframe of core study TAK-664-3001 (NCT04346108) (Max approximately 1.5 year) and of current extension study (Max approximately 3 years) as data of this outcome measu | — |
Contacts
Public ContactTrial Information Contact for Clinical
Takeda Pharmaceutical Company Limited
Outcome results
None listed