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Immunoglobulin Replacement Therapy

Active Drug for Humoral Immunity

Phase 4
Waitlist Available
Research Sponsored by ADMA Biologics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours after each infusion through study completion, up tp approximately 7 months
Awards & highlights

Study Summary

This trial is being conducted to generate additional data on the safety and pharmacokinetics of BIVIGAM in children and adolescents with primary immune deficiencies.

Eligible Conditions
  • Humoral Immunity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours after each infusion through study completion, up tp approximately 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours after each infusion through study completion, up tp approximately 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Reactions
Infusion Site Reactions
Non-treatment Emergent Adverse Events
+10 more
Secondary outcome measures
AUC(0-ʈ)
AUC(0-∞)
Antibodies
+15 more

Side effects data

From 2021 Phase 4 trial • 42 Patients • NCT03116347
32%
Rhinitis
32%
Cough
16%
Upper respiratory tract infection
16%
Pyrexia
11%
Pneumonia
11%
Respiratory tract infection
11%
Epistaxis
11%
Oropharyngeal pain
5%
Diarrhoea
5%
Contusion
5%
Conjunctival haemorrhage
5%
Infusion site pain
5%
Fatigue
5%
Haemangioma
5%
Blood immunoglobulin G decreased
5%
Eye pain
5%
Inflammatory bowel disease
5%
Bacterial infection
5%
Radius fracture
5%
Impetigo
5%
Neutropenia
5%
Nasopharyngitis
5%
Pharyngotonsillitis
5%
Sinusitis
5%
Bronchiectasis
5%
Solar urticaria
5%
Pilonidal cyst
5%
Dental caries
5%
Acute sinusitis
5%
Otitis media
5%
Rhinorrhoea
5%
Dysmenorrhoea
5%
Idiopathic orbital inflammation
5%
Vomiting
5%
Application site pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
HyQvia Pre-treated
HyQvia New Starters

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active DrugExperimental Treatment1 Intervention
All subjects will receive Bivigam based on their prior dosing to be adjusted as clinically necessary.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human immunoglobulin G
FDA approved

Find a Location

Who is running the clinical trial?

ADMA Biologics, Inc.Lead Sponsor
6 Previous Clinical Trials
362 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for participants in this investigation?

"Unfortunately, the medical study is no longer seeking participants. Its initial post was on December 29th 2016, and it has not been updated since September 13 2022. For individuals still searching for studies related to antibody deficiencies, there are 85 trials that have open recruitment and 35 more recruiting patients for this specific treatment."

Answered by AI

Are there any prior investigations related to this therapeutic approach?

"Montefiore Medical Center initiated the study of this treatment in 2008 and since then, 166 clinical trials have concluded. Currently, there are 35 studies conducting research on this intervention with a significant proportion being conducted within Durham and Oklahoma."

Answered by AI

Who qualifies to participate in this clinical research trial?

"In order to enroll in this investigational study, participants should have a primary antibody deficiency and be between 2-16 years of age. There is space for 16 applicants in total."

Answered by AI

For what pathology is this remedy usually prescribed?

"This therapy is regularly used to treat Bruton's agammaglobulinemia and can be prescribed in some cases of primary immunodeficiencies (PID), agammaglobulinemia, and chronic inflammatory demyelinating polyradiculoneuropathy."

Answered by AI

Does this research protocol accommodate individuals aged 70 or above?

"The trial necessitates that enrolled participants are between 2 and 16 years old, in accordance with the specified inclusion criteria."

Answered by AI

To what extent is the participant pool of this research endeavor expanding?

"Unfortunately, this clinical trial is not currently recruiting patients. It was initially published on December 29th 2016 and last updated on September 13th 2022. Alternately, there are 85 trials open for participants with primary antibody deficiencies and 35 studies presently seeking volunteers to test a certain therapy."

Answered by AI

What desired results are expected from this clinical investigation?

"ADMA Biologics, Inc., the sponsor of this trial, has identified Serious Adverse Events as its primary objective. This metric will be measured over a roughly 7-month timespan. Secondary outcomes to be assessed include Total IgG Trough (taken before infusion), AUC(0-ʈ) (a pharmacokinetic measure at 5th or 7th infusion), and Total IgG Post (end of infusion levels)."

Answered by AI

What potential risks should patients be aware of before opting for this treatment?

"The safety of this treatment has been confirmed by the results from Phase 4 trials, resulting in a score of 3."

Answered by AI

In how many locations is this experiment actively underway?

"Five locations have signed up to participate in this trial, such as Duke University Medical Center and Oklahoma Institute of Allergy and Asthma Clinical Research. Additionally, there are 3 additional sites including USF Health that will also be recruiting patients for the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16
2016. "Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03164967.
~2 spots leftby May 2025
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