Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Im… (NCT04565015) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
United States, Bosnia and Herzegovina, Serbia24 participantsStarted 2020-12-21
Plain-language summary
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
Who can participate
Age range
2 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must be ≥ 2 to \< 17 years of age, at the time of signing the informed consent
* Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia
* Subject who has received 300 - 900 mg/kg of IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
* Subject who has at least 2 documented plasma IgG trough level of ≥ 500 mg/dL at two infusion cycles (21 or 28 days) within 12 months prior to enrollment
* Subject who is willing to comply with all requirements of the protocol
Exclusion Criteria:
* Subject who has a history of clinically significant reactions or hypersensitivity to IGIV or other injectable forms of IgG
* Subject who has IgA deficiency and is known to have antibodies to IgA
* Subject who has secondary immunodeficiency
* Subject who has participated in another clinical study (other than an IGIV study) within 3 weeks prior to screening
* Subject who has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency, or who has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
* Subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG
Timeframe: before and after 5th infusion (12 or 16 weeks)
2
The Pharmacokinetic (PK) Half-life of total IgG
Timeframe: before and after 5th infusion (12 or 16 weeks)
3
The Pharmacokinetic (PK) Area under the curve of total IgG
Timeframe: before and after 5th infusion (12 or 16 weeks)
4
The Pharmacokinetic (PK) Volume of distribution of total IgG
Timeframe: before and after 5th infusion (12 or 16 weeks)
5
The Pharmacokinetic (PK) Maximum concentration of total IgG
Timeframe: before and after 5th infusion (12 or 16 weeks)
6
The Pharmacokinetic (PK) Minimum concentration of total IgG
Timeframe: before and after 5th infusion (12 or 16 weeks)
7
The Pharmacokinetic (PK) Time of maximum concentration of total IgG
Timeframe: before and after 5th infusion (12 or 16 weeks)
8
The Pharmacokinetic (PK) Clearance of total IgG
Timeframe: before and after 5th infusion (12 or 16 weeks)
9
Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions
Timeframe: 12 months
10
The proportion of infusions with temporally associated adverse events (AEs) that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product