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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
| Atlantic Research Group | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC5107 | Experimental | GC5107 Immune globulin intravenous (human) solution, 10% liquid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC5107 | Biological | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Within 72 hours after an infusion of GC5107 |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Infections Other Than Acute Serious Bacterial Infections | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Immuno International Research Centers | Centennial | Colorado | 80112 | United States | ||
| Allergy Associates of Palm Beaches PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34305948 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 28-day Schedule | Infusion every 28 days |
| FG001 | 21-day Schedule | Infusion every 21 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2019 | Oct 27, 2021 |
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|
| 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. | 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. | 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. | 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. | One year |
| North Palm Beach |
| Florida |
| 33408 |
| United States |
| Midwest Immunology Clinic and Infusion Center | Plymouth | Minnesota | 55446 | United States |
| Optimed Infusions LLC | Columbus | Ohio | 43235 | United States |
| Oklahoma Institute of Allergy Ashma and Immunology | Oklahoma City | Oklahoma | 73131 | United States |
| Allergy Partners of North Texas Research | Dallas | Texas | 75230 | United States |
| Allergy and Asthma Specialists | Dallas | Texas | 75231 | United States |
| Pediatric Pulmonary Associates of North Texas | Frisco | Texas | 75034 | United States |
| Allergy Asthma and Immunology Clinic PA | Irving | Texas | 75063 | United States |
| Lysosomal Rare Disorder Research and Treatment Center, Inc. | Fairfax | Virginia | 22030 | United States |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2V2 | Canada |
| Hamilton Health Sciences Corporation | Hamilton | Ontario | L8S4K1 | Canada |
| Queen's University - Kingston General Hospital (KGH) | Kingston | Ontario | K7L 2V7 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Gordon Sussman Clinical Research | Toronto | Ontario | M4V 1R2 | Canada |
| Saint Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Hotel Dieu de Montreal | Montreal | Quebec | H2W 1T8 | Canada |
| CHU Ste-Justine - University of Montreal | Montreal | Quebec | H3T 1C5 | Canada |
| McGill University Health Centre (MUHC) - The Montreal Children's Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| Clinique Spécialisée en Allergie de la Capitale | Québec | Quebec | G1V 4W2 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 28-day Infusion | Infusion every 28 days |
| BG001 | 21-day Infusion | Infusion every 21 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Duration since first IVIG infusion | Mean | Standard Deviation | years |
| |||||||||||||||
| IVIG dose prior to enrollment | Mean | Standard Deviation | mg/kg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Number | 99% Confidence Interval | Number of events per patient per year | One year |
|
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| |||||||||||||||||||||||||||||||
| Primary | 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 | 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. | Posted | Number | 95% Confidence Interval | Proportion of infusion with TAAEs | Within 72 hours after an infusion of GC5107 | Total No of infusions | Total No of infusions |
| |||||||||||||||||||||||||||||||
| Secondary | The Incidence of Infections Other Than Acute Serious Bacterial Infections | 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. | Posted | Number | Numberof infections per patient per year | One year |
|
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Days | One year |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Days | One year |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Days | One year |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Days | One year |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Days | One year |
|
One year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GC5107 IVIG 10% | GC5107 IVIG 10% 28-day and 21-day infusion schedule | 0 | 49 | 4 | 49 | 49 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Acute urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| ST elevation myocardial infarction | Cardiac disorders | Systematic Assessment | Occurred after 43 weeks of GC5107 treatment and 22 days after the last infusion prior to the event, Not related to IMP |
| |
| Bacterial pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Squamous cell carcinoma of base of tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
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| Pyrexia | General disorders | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Acute sinusitis | Infections and infestations | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Chest discomfort | General disorders | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Ear pain | Eye disorders | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
| ||
| Infusion site extravasation | General disorders | Non-systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
| ||
| Otitis media | Infections and infestations | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sinus headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Urine analysis abnormal | Investigations | Systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Green Cross Corporation | 82 31 260 9472 | sungsil.lee@gccorp.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2019 | Jan 16, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D012996 | Solutions |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004364 | Pharmaceutical Preparations |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Male |
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| Other |
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| United States |
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| Units | Counts |
|---|---|
| Participants |
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| Total No of infusions |
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28-Day schedule and 21-Day schedule
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| Counts |
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| Participants |
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| Participants |
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