A Phase 3 interventional study of GC5107 in Immunologic Deficiency Syndromes, sponsored by Green Cross Corporation. Completed at 20 sites in 2 countries. Open to participants aged 2 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by Green Cross Corporation · Phase 3, Interventional, and Treatment
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).
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.
Exclusion Criteria:
GC5107 Immune globulin intravenous (human) solution, 10% liquid
Biological: GC5107
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)
Also known as: IGIV, Immune globulin intravenous (human) solution, 10% liquid
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.
Time frame: 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
Time frame: Within 72 hours after an infusion of GC5107
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One year
| Milestone | 28-day Schedule | 21-day Schedule |
|---|---|---|
| Started | 29 | 20 |
| Completed | 24 | 19 |
| Not completed | 5 | 1 |
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.
| Number of events per patient per year | 28-day Schedule | 21-day Schedule | Total |
|---|---|---|---|
| The Incidence of Acute Serious Bacterial Infections (SBI) | 0.04 (NA to 0.35) | 0 (NA to NA) | 0.02 (NA to 0.21) |
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
| Proportion of infusion with TAAEs | 28-day Schedule | 21-day Schedule | Total |
|---|---|---|---|
| The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product | 0.31 (NA to 0.40) | 0.16 (NA to 0.22) | 0.24 (NA to 0.31) |
| Numberof infections per patient per year | 28-day Schedule | 21-day Schedule | Total |
|---|---|---|---|
| The Incidence of Infections Other Than Acute Serious Bacterial Infections | 2.4 | 3.6 | 2.9 |
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.
| Days | 28-day Schedule | 21-day Schedule | Total |
|---|---|---|---|
| The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections | 2.9 ± 4.20 | 12.7 ± 26.11 | 7.1 ± 18.04 |
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.
| Days | 28-day Schedule | 21-day Schedule | GC5107 IVIG 10% |
|---|---|---|---|
| The Number of Days of Unscheduled Physician Visits Due to Infections | 2.3 ± 4.56 | 2.4 ± 2.25 | 2.3 ± 3.75 |
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.
| Days | 28-day Schedule | 21-day Schedule | Total |
|---|---|---|---|
| The Number of Days of Hospitalizations Due to Infections | 0.1 ± 0.57 | 0.1 ± 0.46 | 0.1 ± 0.53 |
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.
| Days | 28-day Schedule | 21-day Schedule | GC5107 IVIG 10% |
|---|---|---|---|
| The Number of Days of Intravenous (IV) Therapeutic Antibiotics | 0.1 ± 0.57 | 0.0 ± 0.00 | 0.1 ± 0.44 |
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.
| Days | 28-day Schedule | 21-day Schedule | GC5107 IVIG 10% |
|---|---|---|---|
| The Number of Days of Oral Therapeutic Antibiotics | 13.3 ± 24.50 | 13.1 ± 18.38 | 13.2 ± 22.09 |
Collected over One year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GC5107 IVIG 10% | 0/49 (0%) | 4/49 (8.2%) | 49/49 (100%) |
| Event | GC5107 IVIG 10% |
|---|---|
| InfluenzaInfections and infestations | 1/49 |
| Acute urticariaSkin and subcutaneous tissue disorders | 1/49 |
| ST elevation myocardial infarctionCardiac disorders | 1/49 |
| Bacterial pneumoniaInfections and infestations | 1/49 |
| Squamous cell carcinoma of base of tongueNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/49 |
| Event | GC5107 IVIG 10% |
|---|---|
| HeadacheNervous system disorders | 28/49 |
| NauseaGastrointestinal disorders | 20/49 |
| CoughRespiratory, thoracic and mediastinal disorders | 15/49 |
| FatigueGeneral disorders | 13/49 |
| PyrexiaGeneral disorders | 13/49 |
| SinusitisInfections and infestations | 13/49 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 11/49 |
| DiarrhoeaGastrointestinal disorders | 9/49 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 9/49 |
| Abdominal pain upperGastrointestinal disorders | 8/49 |
| Age, Continuous(years) | 28-day Infusion | 21-day Infusion | Total |
|---|---|---|---|
| Mean | 41.5 ± 21.7 | 30.7 ± 23.2 | 37.1 ± 22.7 |
| Sex: Female, Male(Participants) | 28-day Infusion | 21-day Infusion | Total |
|---|---|---|---|
| Female | 13 | 8 | 21 |
| Male | 16 | 12 | 28 |
| Race/Ethnicity, Customized(Participants) | 28-day Infusion | 21-day Infusion | Total |
|---|---|---|---|
| White | 28 | 19 | 47 |
| Other | 1 | 1 | 2 |
| Region of Enrollment(Participants) | 28-day Infusion | 21-day Infusion | Total |
|---|---|---|---|
| Canada | 11 | 2 | 13 |
| United States | 18 | 18 | 36 |
| Duration since first IVIG infusion(years) | 28-day Infusion | 21-day Infusion | Total |
|---|---|---|---|
| Mean | 8.8 ± 8.3 | 8.8 ± 6.7 | 8.8 ± 7.6 |
| IVIG dose prior to enrollment(mg/kg) | 28-day Infusion | 21-day Infusion | Total |
|---|---|---|---|
| Mean | 501.2 ± 94.0 | 592.7 ± 135.9 | 538.5 ± 120.6 |
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Immunologic Deficiency Syndromes→
Green Cross Corporation