Immunologic Deficiency SyndromesPhase 3NCT02783482

Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

A Phase 3 study testing GC5107 in people with Immunologic Deficiency Syndromes, run by Green Cross Corporation at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID). Read more about this study

Who is it for?: Ages 2 to 70 years
Conditions the study is for: Immunologic Deficiency Syndromes
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: 49 participants
Where: 20 sitesin 2 countries
Study dates: Oct 2016to Jul 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject 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
Male or Female, ages 2 to 70 years
The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
At least 2 documented IgG trough levels of ≥ 500 mg/dL are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment

Who cannot join

Subject has secondary immunodeficiency
Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin
Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency with known anti-IgA antibodies
History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG
Subject has a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction
Subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment

Trial locations and contacts

20 sites in 2 countries.

Country

City, postcode or hospital

20 sites in 2 countries

United States10 sites

Immuno International Research Centers
Centennial, Colorado, 80112
Optimed Infusions LLC
Columbus, Ohio, 43235
Allergy Partners of North Texas Research
Dallas, Texas, 75230
Allergy and Asthma Specialists
Dallas, Texas, 75231
Lysosomal Rare Disorder Research and Treatment Center, Inc.
Fairfax, Virginia, 22030
Pediatric Pulmonary Associates of North Texas
Frisco, Texas, 75034
Allergy Asthma and Immunology Clinic PA
Irving, Texas, 75063
Allergy Associates of Palm Beaches PA
North Palm Beach, Florida, 33408
Oklahoma Institute of Allergy Ashma and Immunology
Oklahoma City, Oklahoma, 73131
Midwest Immunology Clinic and Infusion Center
Plymouth, Minnesota, 55446

Other trials in United States

Canada10 sites

University of Alberta Hospital
Edmonton, Alberta, T6G 2V2
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8S4K1
Queen's University - Kingston General Hospital (KGH)
Kingston, Ontario, K7L 2V7
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8
CHU Ste-Justine - University of Montreal
Montreal, Quebec, H3T 1C5
McGill University Health Centre (MUHC) - The Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Clinique Spécialisée en Allergie de la Capitale
Québec, Quebec, G1V 4W2
Gordon Sussman Clinical Research
Toronto, Ontario, M4V 1R2
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).

Read the detailed description

This was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study measuring the safety, efficacy and pharmacokinetics and tolerability of GC5107 in subjects with Primary Humoral Immunodeficiency disease (PHID).

Subjects received intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IVIG) maintenance therapy. GC5107 was administered every 21 or 28 days for a period of 12 months.

Conditions: Immunologic Deficiency Syndromes
Being tested: GC5107
Medical subject headings: Immunologic Deficiency Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GC5107Biological
Also called IGIV, Immune globulin intravenous (human) solution, 10% liquid
GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)

Study groups in NCT02783482
Study group	Role	What they receive
GC5107	Experimental	GC5107 Immune globulin intravenous (human) solution, 10% liquid Receives: Biological: GC5107

What is being measured

The primary outcome is the main question the study is designed to answer.

The Incidence of Acute Serious Bacterial Infections (SBI)
The incidence of acute serious bacterial infections (aSBIs) meeting FDA guidance criteria, which includes bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis.
Efficacy data is evaluated by comparing the frequency of acute serious bacterial infections per subject per year according to the FDA guideline of an upper one-sided 99% confidence limit < 1.0 per subject per year.
Measured: One year
The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product
The proportion of infusions with temporally associated adverse events occurring during or within 72 hours following infusion, whether or not they were thought to be related to GC5107
Measured: Within 72 hours after an infusion of GC5107

Secondary outcomes (6)

The Incidence of Infections Other Than Acute Serious Bacterial Infections
Measured: One year
The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections
Based on the total number of days missed from work/school/kindergarten/daycare or days unable to perform normal daily activities due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
Measured: One year
The Number of Days of Unscheduled Physician Visits Due to Infections
Based on the total number of days of unscheduled physician visits due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
Measured: One year
The Number of Days of Hospitalizations Due to Infections
Subject with no experience of specific event will be included in the analysis as zero incidence, zero day, or zero time duration. The mean and SD will be calculated weighting for the duration of data available for each subject.
Measured: One year
The Number of Days of Intravenous (IV) Therapeutic Antibiotics
Based on the total number of days of IV therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit -first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
Measured: One year
The Number of Days of Oral Therapeutic Antibiotics
Based on the total number of days of oral (PO) therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Jul 2019

First posted26 May 2016 (estimated)
Study startOct 2016
Primary completionJul 2019
Study completionJul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Immunologic Deficiency SyndromesStudies of the same condition, open and under way.
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: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02783482
Sponsor's protocol ID: GC5107B_P3
Status last verified: Sep 2022
First submitted: 24 Apr 2016
Last updated: 9 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Perez EE, Hebert J, Ellis AK, Alpan O, Lumry WR, Shapiro R, Suez D, Mandujano JF, Wasserman RL. Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies. Front Immunol. 2021 Jul 8;12:707463. doi: 10.3389/fimmu.2021.707463. eCollection 2021.
PubMed 34305948

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Immunologic Deficiency Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
ClinicalTrials.gov ID: NCT02783482
Acronym / sponsor ID: GC5107B_P3
Conditions: Immunologic Deficiency Syndromes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Green Cross CorporationIndustry (pharma, biotech, devices)
Collaborators: Parexel, Atlantic Research Group
Study start: Oct 2016 (actual)
Primary completion: Jul 2019 (actual)
Study completion: Jul 2019 (actual)
First posted: 26 May 2016 (estimated)
Results: Posted 28 Oct 2022

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 safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).

Detailed description

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: GC5107GC5107 Immune globulin intravenous (human) solution, 10% liquid

Who may qualify

Ages: 2 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Subject 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
Male or Female, ages 2 to 70 years
The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
At least 2 documented IgG trough levels of ≥ 500 mg/dL are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment

Key exclusion criteria (6 listed)

Subject has secondary immunodeficiency
Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin
Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency with known anti-IgA antibodies
History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG
Subject has a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction

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: IGIV, Immune globulin intravenous (human) solution, 10% liquidGC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)	Biological	GC5107

Primary outcome

The Incidence of Acute Serious Bacterial Infections (SBI)
Time frame: One year
The incidence of acute serious bacterial infections (aSBIs) meeting FDA guidance criteria, which includes bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis. Efficacy data is evaluated by comparing the frequency of acute serious bacterial infections per subject per year according to the FDA guideline of an upper one-sided 99% confidence limit < 1.0 per subject per year.
The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product
Time frame: Within 72 hours after an infusion of GC5107
The proportion of infusions with temporally associated adverse events occurring during or within 72 hours following infusion, whether or not they were thought to be related to GC5107

6 secondary outcomes

The Incidence of Infections Other Than Acute Serious Bacterial Infections
Time frame: One year
The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections
Time frame: One year
The Number of Days of Unscheduled Physician Visits Due to Infections
Time frame: One year
The Number of Days of Hospitalizations Due to Infections
Time frame: One year
The Number of Days of Intravenous (IV) Therapeutic Antibiotics
Time frame: One year
The Number of Days of Oral Therapeutic Antibiotics
Time frame: One year

Results and safety

Results posted to the registry on 28 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
28-day Schedule	29	24
21-day Schedule	20	19

Primary outcome: The Incidence of Acute Serious Bacterial Infections (SBI)

Time frame: One year. Number (99% Confidence Interval). Unit: Number of events per patient per year

Measure	28-day Schedule n = 29	21-day Schedule n = 20	Total n = 49
Value	0.04 (NA to 0.35)	0 (NA to NA)	0.02 (NA to 0.21)

Population analysed: Intent-to-Treat (ITT) Population: Defined as of all subjects who were enrolled into the study and received any amount of the IMP. This population was used for display of demographics, disposition, and for the primary safety and efficacy analyses

Primary outcome: The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product

Time frame: Within 72 hours after an infusion of GC5107. Number (95% Confidence Interval). Unit: Proportion of infusion with TAAEs

Measure	28-day Schedule n = 29	21-day Schedule n = 20	Total n = 49
Value	0.31 (NA to 0.40)	0.16 (NA to 0.22)	0.24 (NA to 0.31)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: One year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GC5107 IVIG 10%	4 of 49 (8.2%)	49 of 49 (100%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34305948Perez EE, Hebert J, Ellis AK, Alpan O, Lumry WR, Shapiro R, Suez D, Mandujano JF, Wasserman RL. Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies. Front Immunol. 2021 Jul 8;12:707463. doi: 10.3389/fimmu.2021.707463. eCollection 2021.
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.

20 sites in 2 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 Immunologic Deficiency Syndromes, run by Green Cross Corporation at 20 sites in 2 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 4 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: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 28 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Incidence of Acute Serious Bacterial Infections (SBI) (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02783482, which also lists 1 linked publication.

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 9 Dec 2022.