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

January 30, 2023 updated by: ADMA Biologics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Centennial, Colorado, United States, 80112
        • IMMUNOe Research Centers
    • Florida
      • Durham, Florida, United States, 27710
        • Duke University Medical Center
      • North Palm Beach, Florida, United States, 33408
        • Allergy Associates of the Palm Beaches
      • Saint Petersburg, Florida, United States, 33701
        • USF Health, Pediatric Allergy, Immunology & Rheumatology
    • Ohio
      • Mayfield Heights, Ohio, United States, 44124
        • Ohio Clinical Research Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73131
        • Oklahoma Institute of Allergy and Asthma Clinical Research
    • Texas
      • Dallas, Texas, United States, 75225
        • Discovery Clinical Trials
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Lysosomal Rare Disorders Research & Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Active Drug
All subjects will receive Bivigam based on their prior dosing to be adjusted as clinically necessary.
Biological: Bivigam

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Temporally Associated Adverse Events
Time Frame: During each infusion (During or within 1 hour, 24 hours and 72 hours of completion of an infusion)
Incidence of adverse events (During or within 1 hour, 24 hours and 72 hours of completion of an infusion)
During each infusion (During or within 1 hour, 24 hours and 72 hours of completion of an infusion)
Number of Temporally Associated Adverse Events
Time Frame: Up to 72 hours of completion of an infusion
Mean number of temporally associated per infusion
Up to 72 hours of completion of an infusion
Serious Adverse Events
Time Frame: Up to approximately 7 months
Incidence of serious adverse events
Up to approximately 7 months
Related Serious Adverse Events
Time Frame: Up to approximately 7 months
Incidence of related serious adverse events
Up to approximately 7 months
Treatment Emergent Adverse Events
Time Frame: Up to approximately 7 months
Incidence of treatment emergent adverse events
Up to approximately 7 months
Related Treatment Emergent Averse Events
Time Frame: Within 72 hours of infusion
Incidence of adverse events that first appear, or that worsen relative to the pre-treatment state, which occur during and within 72 hours of treatment administration
Within 72 hours of infusion
Non-treatment Emergent Adverse Events
Time Frame: Up to approximately 7 months
Incidence of adverse events which do not have a causal relationship with study treatment
Up to approximately 7 months
Temporally Associated Infusion Adverse Events
Time Frame: Up to approximately 7 months
Incidence of adverse events which have a causal relationship with infusion treatment
Up to approximately 7 months
Adverse Reactions
Time Frame: Up to approximately 7 months
Number and incidence of adverse reactions plus suspected adverse reactions combined
Up to approximately 7 months
Related Adverse Reactions
Time Frame: Up to approximately 7 months
Incidence of adverse infusion related reactions
Up to approximately 7 months
Infusion Site Reactions
Time Frame: Up to approximately 7 months
Incidence reactions occuring at the infusion site
Up to approximately 7 months
Vital Signs
Time Frame: Before and after each administration of study drug through study completion, up to approximately 7 months
Change in vital signs
Before and after each administration of study drug through study completion, up to approximately 7 months
Temporally Associated Adverse Events Following Infusions
Time Frame: Up to 72 hours after each infusion through study completion, up tp approximately 7 months
Incidence of adverse events
Up to 72 hours after each infusion through study completion, up tp approximately 7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total IgG Trough
Time Frame: At each visit through study completion, up tp approximately 7 months
Levels taken before any infusion
At each visit through study completion, up tp approximately 7 months
IgG subclasses
Time Frame: Prior to first and last infusion, up tp approximately 7 months
Levels of subclasses 1- 4 before infusion
Prior to first and last infusion, up tp approximately 7 months
Total IgG Post
Time Frame: At each infusion through study completion, up tp approximately 7 months
End of infusion level of Total IgG
At each infusion through study completion, up tp approximately 7 months
Cmax
Time Frame: At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Pharmacokinetic measure at 5th or 7th infusion
At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Tmax
Time Frame: At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Pharmacokinetic measure at 5th or 7th infusion
At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
AUC(0-ʈ)
Time Frame: At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Pharmacokinetic measure at 5th or 7th infusion
At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
AUC(0-∞)
Time Frame: At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after infusion
Pharmacokinetic measure at 5th or 7th infusion
At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after infusion
Terminal phase elimination half-life (ʈ½)
Time Frame: At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Pharmacokinetic measure at 5th or 7th infusion
At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Antibodies
Time Frame: At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Levels of specific antibodies (antipneumococcal capsular polysaccharide, antihaemophilus influenza B
At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Infections
Time Frame: Up to approximately 7 months
Number of infections of any kind, serious and non-serious
Up to approximately 7 months
First Serious Bacterial Infection
Time Frame: Up to approximately 7 months
Time to first Serious Bacterial Infections in days
Up to approximately 7 months
Serious Bacterial Infections
Time Frame: Up to approximately 7 months
Incidence of Serious Bacterial Infections
Up to approximately 7 months
Other Infections
Time Frame: Up to approximately 7 months
Incidence of infections other than Serious Bacterial Infections
Up to approximately 7 months
Resolution of Infections
Time Frame: Up to approximately 7 months
Time to resolution of Infections in days
Up to approximately 7 months
Fever
Time Frame: Up to approximately 7 months
Episodes of Fever
Up to approximately 7 months
Missed Days
Time Frame: Up to approximately 7 months
Number of days missed of school or work due to infections and treatment
Up to approximately 7 months
Hospitalizations
Time Frame: Up to approximately 7 months
Number of hospitalizations due to infections
Up to approximately 7 months
Terminal phase elimination rate (λZ)
Time Frame: At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months
Pharmacokinetic measure at 5th or 7th infusion
At prior to, at end of infusion, and 6 hours, 24 hours, 7 days, and 4 days, 21 days and 28 days (if still enrolled) after final infusion, up tp approximately 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ADMA Biologics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 994

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not yet determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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