Study to Evaluate Safety & Pharmacokinetics of BIVIGAM® in Primary Immune

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

This study is part of the BIVIGAM® post marketing requirement (PMR). It is being conducted in subjects aged 2-16 with primary immune deficiency disorders associated with defects in humoral immunity to generate additional data on these populations, and more specifically safety and pharmacokinetic (PK) assessments.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT03924076` - Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Elementary School Children	N/A

NCT number	NCT03164967
Study type	Interventional
Source	ADMA Biologics, Inc.
Contact
Status	Completed
Phase	Phase 4
Start date	December 29, 2016
Completion date	December 31, 2022

Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms