Primary Immune DeficiencyPhase 3NCT04565015
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
A Phase 3 study testing GC5107 in people with Primary Immune Deficiency, run by GC Biopharma Corp at 8 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Primary Immune Deficiency
- What is being tested?
- GC5107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 21 Dec 2020to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States5 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Immunoe Health & Research Centers
Centennial, Colorado, 80112
Allergy Partners of North Texas Research
Dallas, Texas, 75230
Lysosomal and Rare Disorders Research and Treatment Center, Inc.
Fairfax, Virginia, 22030
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219
Bosnia and Herzegovina2 sites
University Clinical Center Sarajevo
Sarajevo, Sarajevo, 71000
University clinical center Tuzla
Tuzla, Tuzla, 75000
Serbia1 site
Institute for Child and Youth Health Care of Vojvodina
Novi Sad, Novi Sad, 21000
About this study
Official title: An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
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).
Read the detailed description
This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged ≥ 2 years and < 17 years with PHID.
Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months.
- Conditions
- Primary Immune Deficiency
- Being tested
- GC5107
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC5107Biological
Also called GCC 10% IGIV, Immune Globulin Intravenous (Human), 10% Liquid
Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months
| Study group | Role | What they receive |
|---|---|---|
| GC5107 | Experimental | Immune Globulin Intravenous (Human), 10% Liquid Receives: Biological: GC5107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Half-life of total IgG
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Area under the curve of total IgG
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Volume of distribution of total IgG
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Maximum concentration of total IgG
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Minimum concentration of total IgG
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Time of maximum concentration of total IgG
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Clearance of total IgG
Measured: before and after 5th infusion (12 or 16 weeks)
Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions
Measured: 12 months
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
AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period
Measured: 12 months
Secondary outcomes (11)
The Pharmacokinetic (PK) Maximum concentration of IgG subclasses
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Minimum concentration of IgG subclasses
Measured: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Half-life of IgG subclasses
Measured: before and after 5th infusion (12 or 16 weeks)
Trough serum level of IgG subclasses and specific IgG antibodies before Infusion 1 and 13 (for subjects on 28-day infusion schedule) or Infusion 1 and 17 (for subjects on 21-day infusion schedule)
Measured: 12 months
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)
Measured: 12 months
The overall incidence of all AEs that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product
AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period
Measured: 12 months
The frequency of all AEs that occur during the study regardless of the investigator's assessment of their relationship to investigational product
Measured: 13 months (12 months of treatment + 1 month of follow-up)
The frequency of suspected adverse reactions as defined by all AEs either classified as at least possibly related to GC5107
Measured: 13 months (12 months of treatment + 1 month of follow-up)
The number and proportion of GC5107 infusions for which the infusion rate was decreased due to AEs
Measured: 12 months
The proportion of AEs considered by the investigator to be investigational product related
Measured: 13 months (12 months of treatment + 1 month of follow-up)
Viral safety (freedom from transmission of blood-borne viral diseases): the human immunodeficiency virus (HIV) type 1 & 2, hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), and parvovirus B19
Measured: 13 months (12 months of treatment + 1 month of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start21 Dec 2020
- Primary completionMay 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by GC Biopharma CorpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GC Biopharma Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565015
- Sponsor's protocol ID
- GC5107D
- Status last verified
- Jul 2025
- First submitted
- 7 Sep 2020
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
- ClinicalTrials.gov ID
- NCT04565015
- Acronym / sponsor ID
- GC5107D
- Conditions
- Primary Immune Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- GC Biopharma CorpIndustry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged ≥ 2 years and < 17 years with PHID.
Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC5107 | Experimental | Biological: GC5107Immune Globulin Intravenous (Human), 10% Liquid |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC5107Also: GCC 10% IGIV, Immune Globulin Intravenous (Human), 10% LiquidIntravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months | Biological | GC5107 |
Primary outcome
The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Half-life of total IgG
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Area under the curve of total IgG
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Volume of distribution of total IgG
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Maximum concentration of total IgG
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Minimum concentration of total IgG
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Time of maximum concentration of total IgG
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Clearance of total IgG
Time frame: before and after 5th infusion (12 or 16 weeks)
Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions
Time frame: 12 months
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
Time frame: 12 months
AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period
11 secondary outcomes
The Pharmacokinetic (PK) Maximum concentration of IgG subclasses
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Minimum concentration of IgG subclasses
Time frame: before and after 5th infusion (12 or 16 weeks)
The Pharmacokinetic (PK) Half-life of IgG subclasses
Time frame: before and after 5th infusion (12 or 16 weeks)
Trough serum level of IgG subclasses and specific IgG antibodies before Infusion 1 and 13 (for subjects on 28-day infusion schedule) or Infusion 1 and 17 (for subjects on 21-day infusion schedule)
Time frame: 12 months
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)
Time frame: 12 months
The overall incidence of all AEs that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product
Time frame: 12 months
The frequency of all AEs that occur during the study regardless of the investigator's assessment of their relationship to investigational product
Time frame: 13 months (12 months of treatment + 1 month of follow-up)
The frequency of suspected adverse reactions as defined by all AEs either classified as at least possibly related to GC5107
Time frame: 13 months (12 months of treatment + 1 month of follow-up)
The number and proportion of GC5107 infusions for which the infusion rate was decreased due to AEs
Time frame: 12 months
The proportion of AEs considered by the investigator to be investigational product related
Time frame: 13 months (12 months of treatment + 1 month of follow-up)
Viral safety (freedom from transmission of blood-borne viral diseases): the human immunodeficiency virus (HIV) type 1 & 2, hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), and parvovirus B19
Time frame: 13 months (12 months of treatment + 1 month of follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GC5107 in people with Primary Immune Deficiency, run by GC Biopharma Corp at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Bosnia and Herzegovina, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG (time frame: before and after 5th infusion (12 or 16 weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.