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Immunoglobulin Replacement Therapy

Asceniv™ for Primary Immune Deficiency

Phase 4
Recruiting
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 approximately 7 months
Awards & highlights

Study Summary

This trial is testing a new medication for children with Primary Immunodeficiency Diseases. The medication will be given intravenously every 21 or 28 days, and children will receive six to seven doses during the study.

Eligible Conditions
  • Primary Immune Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
AUC(0-ʈ)
AUC(0-∞)
Cmax
+3 more
Secondary outcome measures
Antibodies
Hospitalizations
IgG Subclasses
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AscenivExperimental Treatment1 Intervention
Asceniv™ will be given as an intravenous infusion at the same dose, or higher dose where medically appropriate, as the subject's previous IV Immunoglobulin G treatment (300-800 mg/kg) every 21 or 28 days.

Find a Location

Who is running the clinical trial?

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

Frequently Asked Questions

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

Is this study available to individuals below the age of fifty-five?

"In agreement with the trial's requirements, children aged between 2 and 11 may be considered for enrollment."

Answered by AI

How many study participants are engaged in this investigation?

"The study necessitates the recruitment of 12 eligible participants. ADMA Biologics, Inc., is the sponsor and has chosen Medical University of South carolina in Charleston, South Carolina and University of Utah in Salt Lake City, Utah as potential sites for this clinical trial."

Answered by AI

Are there any previous studies which have incorporated Asceniv™ as part of their research?

"The research of Asceniv™ began in 2008 at Montefiore Medical Center. Since then, 166 trials have been completed world-wide with 35 still ongoing, primarily concentrated around Charleston, South carolina."

Answered by AI

What potential risks are associated with using Asceniv™?

"Data collected throughout the Phase 4 trial suggests that Asceniv™ is a safe intervention, earning it an overall ranking of 3."

Answered by AI

What is the ultimate objective of this trial?

"The main end-point of this trial, which will be measured at time points preceding the infusion and afterwards for up to 28 days depending on the schedule, is Cmax. Secondary outcomes involve a survey of IgG Subclasses (1-4), antibodies targeting specific infections, and monitoring Serious Bacterial Infections prevalence among participants."

Answered by AI

In what clinical situations is Asceniv™ typically prescribed?

"Asceniv™ is primarily used to manage bruton's agammaglobulinemia, and can also be leveraged in many other situations such as PIDs, agammaglobulinemias, and chronic inflammatory demyelinating polyradiculoneuropathies."

Answered by AI

Could I qualify for the clinical trial currently in progress?

"Eligibility criteria for this medical trial includes being between the ages of 2 and 11, as well as having primary immune deficiency. The research team is seeking to recruit 12 participants in total."

Answered by AI

Are there still opportunities for participants to enroll in this trial?

"Affirmative. As per the data from clinicaltrials.gov, this medical trial is still recruiting participants since its first posting on September 1st 2022 and recent updates on the 13th of that month. A total of 12 patients are required at 3 separate medical centres."

Answered by AI
~5 spots leftby Apr 2025