Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Humoral Immunity
  • Age: Between 2 - 16 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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