An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)
Status unknown · Phase 4 · NCT05070455
Conditions: Primary Immune Deficiency
At a glance
- Research payments reported, 2025
- $174,235
- U.S. investigators named
- 0
- Sites paid
- 0
- Planned or actual enrollment
- 12
About the trial
- Sponsor
- ADMA Biologics, Inc.
- Tested
- Asceniv™ (biological)
- Dates
- Started 2022-09-01; completion 2023-06-30
- Results posted
- Not yet
This is a Phase IV, multicenter, open-label study of Asceniv™ administered as an intravenous infusion of Asceniv™ (IGIV) 300-800 mg/kg every 21 or 28 days in approximately 12 pediatric subjects with Primary Immunodeficiency Diseases (PIDD). The study will be conducted at 5-7 centers in the United States, with subjects receiving six (28 day cycle) or seven (21 day cycle) doses of Asceniv™ during the study.
From ClinicalTrials.gov, last updated 2022-09-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Adma Biomanufacturing LLC reported $174,235 in research payments for this study in 2025 (16 payments).
Products named: Asceniv
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
Sites paid to run it
- $174,235
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.