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Immunoglobulin

GC5107 for Primary Immune Deficiency

Phase 3
Recruiting
Research Sponsored by Green Cross Corporation
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 13 months (12 months of treatment + 1 month of follow-up)
Awards & highlights

Study Summary

This trial will study how well a new immune globulin works in kids with Primary Humoral Immunodeficiency, a disease that impairs the body's ability to fight infection.

Eligible Conditions
  • Primary Immune Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months (12 months of treatment + 1 month of follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 months (12 months of treatment + 1 month of follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Pharmacokinetic (PK) Area under the curve of total IgG
The Pharmacokinetic (PK) Clearance of total IgG
The Pharmacokinetic (PK) Half-life of total IgG
+7 more
Secondary outcome measures
Number and proportion of subjects who failed to meet the target IgG trough level (500 mg/dL) at any time point equal to or subsequent to 5th infusion (estimated 5 half-lives)
The Pharmacokinetic (PK) Half-life of IgG subclasses
The Pharmacokinetic (PK) Maximum concentration of IgG subclasses
+8 more
Other outcome measures
Episodes of fever (annual rate of fever episodes per subject)
The incidence of acute serious bacterial infections (aSBIs) defined at United States Food and Drug Administration (FDA) guidance criteria (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis)
The incidence of infections by trough IgG levels
+8 more

Side effects data

From 2019 Phase 3 trial • 49 Patients • NCT02783482
57%
Headache
41%
Nausea
31%
Cough
27%
Sinusitis
27%
Pyrexia
27%
Fatigue
22%
Oropharyngeal pain
18%
Nasal congestion
18%
Diarrhoea
16%
Abdominal pain upper
16%
Vomiting
14%
Rhinorrhoea
12%
Arthralgia
12%
Bronchitis
12%
Influenza
12%
Nasopharyngitis
12%
Upper respiratory tract infection
10%
Urinary tract infection
10%
Epistaxis
10%
Sinus congestion
10%
Urticaria
10%
Acute sinusitis
8%
Viral infection
8%
Abdominal pain
8%
Asthma
8%
Rash
6%
Pain
6%
Productive cough
6%
Asthenia
6%
Musculoskeletal chest pain
6%
Otitis media
6%
Dizziness
6%
Ear pain
6%
Infusion site extravasation
6%
Sinus headache
6%
Viral upper respiratory tract infection
6%
Urine analysis abnormal
6%
Gastroenteritis viral
6%
Pain in extremity
6%
Chest discomfort
6%
Contusion
6%
Non-cardiac chest pain
2%
Squamous cell carcinoma of base of tongue
2%
Acute urticaria
2%
ST elevation myocardial infarction
2%
Bacterial pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
GC5107 IVIG 10%

Trial Design

1Treatment groups
Experimental Treatment
Group I: GC5107Experimental Treatment1 Intervention
Immune Globulin Intravenous (Human), 10% Liquid
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GC5107
2016
Completed Phase 3
~50

Find a Location

Who is running the clinical trial?

Green Cross CorporationLead Sponsor
81 Previous Clinical Trials
24,019 Total Patients Enrolled
Atlantic Research GroupOTHER
8 Previous Clinical Trials
571 Total Patients Enrolled

Media Library

GC5107 (Immunoglobulin) Clinical Trial Eligibility Overview. Trial Name: NCT04565015 — Phase 3
Primary Immune Deficiency Research Study Groups: GC5107
Primary Immune Deficiency Clinical Trial 2023: GC5107 Highlights & Side Effects. Trial Name: NCT04565015 — Phase 3
GC5107 (Immunoglobulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04565015 — Phase 3

Frequently Asked Questions

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

If a person is under 35, can they join this clinical trial?

"According to the study's inclusion criteria, children aged 2-16 can participate."

Answered by AI

How many people are participating in this clinical trial?

"In order to run this experiment, 24 individuals that meet the necessary requirements must be found. Green Cross Corporation is funding and running the trial from various hospitals including Children's Hospital of Richmond at VCU in Richmond, Virginia and Allergy Partners of North Texas Research in Dallas, Texas."

Answered by AI

What other medical papers have been published about GC5107?

"GC5107 was first studied a little over a decade ago, in 2008. To date, there have been 166 completed clinical trials and 37 ongoing ones. The majority of the active clinical trials for this medication are based in Richmond, Virginia."

Answered by AI

Could I be a candidate for this clinical research?

"This study is enrolling 24 participants with antibody deficiency syndrome between the ages of 2 and 16. Most importantly, applicants are required to meet the following 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"

Answered by AI

Are patients still being accepted into this research program?

"Yes, this trial is recruiting according to the latest information on clinicaltrials.gov. The listing was first created on December 21st, 2020 and updated November 15th, 2022."

Answered by AI

What are some primary indications for GC5107?

"GC5107 is most frequently used to treat bruton's agammaglobulinemia, but it can also be an effective medication for patients suffering from primary immunodeficiencies (pid), agammaglobulinemia, and chronic inflammatory demyelinating polyradiculoneuropathy."

Answered by AI

Could you please elaborate on the risks associated with GC5107?

"GC5107 has been deemed safe by our team, as it is a Phase 3 trial with supporting efficacy data and rounds of safety testing."

Answered by AI

Are many research centers in North America hosting this trial?

"4 enrolment sites for this clinical trial include the Children's Hospital of Richmond at VCU in Richmond, Allergy Partners of North Texas Research in Dallas, and Lysosomal and Rare Disorders Research and Treatment Center, Inc. in Fairfax. 4 other locations are also participating."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
2020. "Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04565015.
~6 spots leftby Apr 2025
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