WithdrawnPhase 3

Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency

Stopped: A change in sponsor's developmental strategy

0Started 2019-04-30

Plain-language summary

To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)

Who can participate

Age range

24 Months – 203 Months

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: * Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia * Subject is willing to comply with all requirements of protocol * Authorization to access personal health information Exclusion Criteria: * Subject has secondary immunodeficiency * Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG * Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia

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

Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)

Timeframe: 13 months (12 months of treatment + 1 month of Follow-Up)

Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug

Timeframe: 13 months (12 months of treatment + 1 month of Follow-Up)

Trial details

NCT IDNCT03492710

SponsorGreen Cross Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-30

View on ClinicalTrials.gov More Primary Immune Deficiency Disorder trials

Who can participate

Age range

24 Months – 203 Months

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.