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Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16 | Clinical Trials | Clareo Health

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

A Phase IV, Multicenter, Open-label Study to Evaluate the Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Disorders in Subjects Aged 2 to 16

NCT03164967•ADMA Biologics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 16 years

Sex

ALL

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.
+8 more criteria

Locations (8)

IMMUNOe Research Centers

Centennial, Colorado, United States

Duke University Medical Center

Durham, Florida, United States

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, United States

USF Health, Pediatric Allergy, Immunology & Rheumatology

St. Petersburg, Florida, United States

Ohio Clinical Research Associates

Mayfield Heights, Ohio, United States

Oklahoma Institute of Allergy and Asthma Clinical Research

Oklahoma City, Oklahoma, United States

Discovery Clinical Trials

Dallas, Texas, United States

Lysosomal Rare Disorders Research & Treatment Center

Fairfax, Virginia, United States

Key Dates

Start Date

December 29, 2016

Primary Completion Date

August 30, 2022

Completion Date

December 31, 2022

Last Updated

February 1, 2023

Enrollment

ACTUAL participants

Conditions

Humoral Immune Response

Interventions

Bivigam

BIOLOGICAL