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Asceniv™ for Primary Immune Deficiency
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.
- Primary Immune Deficiency
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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