Primary Immunodeficiency Diseases (PID) Clinical Trial
Official title:
A Phase 3, Open-label, Non-controlled, Multi-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Subjects With Primary Immunodeficiency Diseases (PID)
In this study, Japanese participants with primary immunodeficiency diseases were treated with Immune Globulin Subcutaneous (Human), 20% solution, (IGSC, 20%). This study will be in 3 parts: Part 1: Infusions with Immunoglobulin Intravenous (IGIV) every 3 or 4 weeks for 13 weeks. Part 2: Participants will switch to weekly subcutaneous infusions with IGSC, 20% for 24 weeks. Part 3: A subset will receive biweekly subcutaneous infusions with IGSC, 20% for 12 weeks. The main aim of the study is to assess base levels of Immunoglobulin globulin G (IgG) levels in the blood of the participants after weekly and biweekly treatment with IGSC, 20% (in Parts 2 and 3 of the study). Their PID will be treated by their doctor according to their doctor's usual clinical practice.
This study consists of 3 treatment parts (Epoch 1, 2, 3). The total evaluation period of the study will be 57 weeks in which screening period is for 2-8 weeks and Epoch 1 is from Week 8 to Week 21, Epoch 2 is from Week 21 to Week 45, Epoch 3 is from Week 45 to Week 57. Each participant will receive IGIV treatment in Epoch 1 for a total of 13 weeks, then switch to weekly subcutaneous (SC) treatment with IGSC, 20% in Epoch 2 for a total of 24 weeks and will continue into Epoch 3 for a total of 12 weeks of biweekly SC treatment with IGSC, 20%. Drug dose in Epoch 2 and Epoch 3 will be adjusted so that it will be an equivalent weekly dose of the dose administered in Epoch 1 and twice the dose administrated in Epoch 2 respectively. Epoch 2 will contain two periods, period 1: dose adjustment period (first 12 weeks) and period 2: evaluation period (second 12 weeks). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03277313 -
Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
|
Phase 3 | |
| Completed |
NCT03716700 -
Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
|
||
| Active, not recruiting |
NCT05513586 -
A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
|
Phase 3 | |
| Recruiting |
NCT05986734 -
Evaluation of Subcutaneous Immunoglobulin Product Cutaquig in Terms of Safety and Efficacy in the Treatment of Patients With Primary Immunodeficiencies
|
||
| Completed |
NCT00546871 -
Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05755035 -
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
|
Phase 2/Phase 3 | |
| Completed |
NCT02593188 -
Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
|
||
| Completed |
NCT03116347 -
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
|
Phase 4 | |
| Completed |
NCT00157079 -
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
|
Phase 3 | |
| Completed |
NCT01412385 -
Immune Globulin Subcutaenous (Human), 20%
|
Phase 2/Phase 3 | |
| Completed |
NCT00161993 -
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
|
Phase 2 | |
| Completed |
NCT01175213 -
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
|
Phase 3 | |
| Completed |
NCT01218438 -
Phase 2/3 Study of IGSC, 20% in PIDD
|
Phase 2/Phase 3 | |
| Completed |
NCT05150340 -
A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)
|
Phase 3 | |
| Not yet recruiting |
NCT06076642 -
A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
|
Phase 3 | |
| Completed |
NCT00782106 -
Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously
|
Phase 1/Phase 2 | |
| Completed |
NCT01485796 -
Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06150534 -
At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
|
||
| Completed |
NCT00814320 -
Gammagard Liquid and rHuPH20 in PID
|
Phase 3 |