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

ADMA Biologics

Status and phase

Completed

Phase 4

Conditions

Humoral Immune Response

Treatments

Biological: Bivigam

Study type

Interventional

Funder types

Industry

Identifiers

NCT03164967

994

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent/Assent
Male or female between 2 and 16 years, inclusive, at time of Signing Informed Consent/Assent
Have a confirmed and documented clinical diagnosis of Primary Immune Deficiency Disorder, including hypogammaglobulinemia or agammaglobulinemia.
Have received IGIV therapy which was maintained at a steady dose (± 25% of the mean dose) for at least 3 months prior to study entry, and have maintained a trough IgG level at least 500mg/dL prior to receiving BIVIGAM®.
Subjects and/or parents/legal guardians must be able to understand and adhere to the study visit schedule and all other protocol requirements.

Exclusion criteria

Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction).
Known intolerance to proteins of human origin or known allergic reactions to components of the study product(s).
Any previous randomization/participation in this clinical study must be discussed with and approved by the medical director (or designee).
Inability or lacking motivation to participate in the study.
Medical condition, laboratory finding, or physical exam finding (specify, e.g., vital signs outside of specific range that precludes participation. Per lab results at the Screening visit through Baseline.
Confirmed Screening visit laboratory results ˃2.5 X ULN as defined for pediatric populations for any of the following: ALT (alanine aminotransferase/SGPT), AST (aspartate aminotransferase/SGOT), LDH (lactate dehydrogenase), BUN (blood urea nitrogen), Serum creatinine
Has selective IgA deficiency or demonstrated antibodies to IgA.
History of thrombotic complications of IGIV therapy or history of (deep vein thrombosis)DVT.
Current use of daily corticosteroids (>10 mg of prednisone equivalent/day),immunosuppressants or immunomodulators are not allowed unless approved in advance by the medical monitor. Intermittent use of corticosteroids during the study is allowed if medically necessary.
Positive diagnosis of hepatitis B or hepatitis C.
Positive human immunodeficiency virus (HIV) test.
Subject has had a serious bacterial infection (SBI) within the last 3 months.
Subject has an active infection and is receiving antibiotic therapy for the treatment of this infection at the time of Screening. Note: if the subject is deemed a Screen Failure due to a nonserious active infection requiring antibiotic therapy, the subject may be rescreened 3 or 4 weeks (depending on drug administration schedule) after the initial screening.
Subject has a history of thrombotic events (including deep vein thrombosis, myocardial infarction, cerebrovascular accident and pulmonary embolism) within 6 months before 1st IGIV dose or has preexisting risk factors for thrombotic events.
Acquired medical condition known to cause secondary immune deficiency such as chronic lymphacitic leukemia, lymphoma or multiple lymphoma.
Subjects with protein-losing enteropathies, hypoalbuminaemia.
Females taking oral contraceptives.
Pregnancy or unreliable contraceptive measures or lactation period (females of childbearing potential (female capable of becoming pregnant) only. Males capable of reproduction must agree to a double barrier method of contraception during their study participation.