Conditions: Primary Immunodeficiency Diseases (PID)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 86
Healthy volunteers: no

Brief summary:
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Immune Globulin Intravenous (Human), 10% Solution intervention 2: Immune Globulin Subcutaneous (Human), 20% Solution
Intervention descriptions: intervention 1: Intravenous infusion with IGIV, 10% intervention 2: Subcutaneous infusion with IGSC, 20%

Protocol document: