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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    18
  • sponsor
    ADMA Biologics, Inc.
Updated on 29 January 2022

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.

Details
Condition Humoral Immune Response
Treatment Bivigam
Clinical Study IdentifierNCT03164967
SponsorADMA Biologics, Inc.
Last Modified on29 January 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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