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This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20. The primary objective of this study is to characterize the PK of IgPro20 and to assess the safety and tolerability of IgPro20 in IG treatment-naïve participants with PID who are aged greater than or equal to (>=) 18 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro20 | Experimental | All participants will receive a loading dose of IgPro20 daily from Day 1 to 5 in Week 1, followed by weekly administration of the maintenance dose of IgPro20 from Day 8 (Week 2) to Day 78 (Week 12). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgPro | Biological | IgPro20 is a solution for infusion for subcutaneous administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough concentration (Ctrough) Levels of IgPro20 | Up to Week 13 | |
| Number of Participants Experiencing Any Treatment-Emergent Adverse Event (TEAEs) or Serious TEAEs | Up to Day 85 | |
| Number of TEAEs and Serious TEAEs Events | Up to Day 85 | |
| TEAEs and Serious TEAEs Event Rates Per Days with Infusion | Up to Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Solutions of AZ | Litchfield Park | Arizona | 85340 | United States | ||
| Medical Research of Arizona |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Immunoe Health Centers | Centennial | Colorado | 80112 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Midwest Immunology | Plymouth | Minnesota | 55446 | United States |
| Washington University | St Louis | Missouri | 63141 | United States |
| Allergy, Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Allergy & Clinical Immunology | Pittsburgh | Pennsylvania | 15241 | United States |
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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