An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)

PHASE4UnknownINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

March 31, 2023

Study Completion Date

June 30, 2023

Conditions
Primary Immune Deficiency
Interventions
BIOLOGICAL

Asceniv™

Each subject will receive an intravenous infusion of Asceniv™ on Study Day 1 (required to be within 28 days of screening) and every 21 or 28 days thereafter according to their current interval of IGIV treatment. Subjects will receive Asceniv™ at the same dose or higher dose if medically appropriate (300-800 mg/kg), every 21 or 28 days for five months (seven or six doses respectively).

Trial Locations (3)

29425

RECRUITING

Medical University of South Carolina, Charleston

80112

NOT_YET_RECRUITING

Immunoe Research Centers, Centennial

84112

NOT_YET_RECRUITING

University of Utah, Salt Lake City

Sponsors
All Listed Sponsors
lead

ADMA Biologics, Inc.

INDUSTRY