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The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro10 | Experimental | See Intervention Description |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulins Intravenous (Human) | Drug | Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). | AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion. | During each infusion, and within 48 or 72 hours after the end of each infusion. |
| Influence of Infusion Rate on Temporally-Associated AEs | The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion. | Within 72 hours after each infusion |
| Rate of AEs by Severity and Relationship | The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. | For the duration of the study, up to approximately 29 months |
| Number of Subjects With Clinically Significant Changes in Vital Signs. | Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. | Before, during, and after each infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of Acute Serious Bacterial Infections. | The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess. |
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Key Inclusion Criteria:
Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:
Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)
OR
Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04_009CR) (referred to as 'new' subjects)
Written informed consent
Key Exclusion Criteria:
Diagnosis of epilepsia
Insulin dependent diabetes
Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Program Coordinator | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact CSL Behring for facility details | Los Angeles | California | 90027 | United States | ||
| Contact CSL Behring for facility details |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20217199 | Result | Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IgPro10 | A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| For the duration of the study, up to approximately 29 months |
| Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness. | For the duration of the study, up to approximately 29 months. |
| Number of Days of Hospitalization. | For the duration of the study, up to approximately 29 months |
| Annualized Rate of Any Infection. | The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations" and AEs with the preferred term "conjunctivitis". | For the duration of the study, up to approximately 29 months. |
| Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations. | Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed. | Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule. |
| Centennial |
| Colorado |
| 80112 |
| United States |
| Contact CSL Behring for facility details | North Palm Beach | Florida | 33408 | United States |
| Contact CSL Behring for facility details | St. Petersburg | Florida | 33701 | United States |
| Contact CSL Behring for facility details | Fort Wayne | Indiana | 46815 | United States |
| Contact CSL Behring for facility details | Indianapolis | Indiana | 46202 | United States |
| Contact CSL Behring for facility details | Iowa City | Iowa | 52242 | United States |
| Contact CSL Behring for facility details | Rochester | Minnesota | 55905 | United States |
| Contact CSL Behring for facility details | St Louis | Missouri | 63104-1095 | United States |
| Contact CSL Behring for facility details | Dallas | Texas | 75230 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IgPro10 | A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs). | AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion. | The Safety Data Set (SDS) comprised all subjects treated with the study drug. | Posted | Number | Proportion of infusions | During each infusion, and within 48 or 72 hours after the end of each infusion. | Infusions | Participants |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Influence of Infusion Rate on Temporally-Associated AEs | The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min). AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion. | 'New subjects' could receive IgPro10 at up to 4 mg/kg/min. 'Old' subjects (ie, those treated with the study drug who participated in a preceding, pivotal, Phase III clinical study with intravenous IgPro10 [study number ZLB03_002CR, NCT00168025]), could receive IgPro10 at up to 12 mg/kg/min at the discretion of the Investigator. | Posted | Number | Infusions | Within 72 hours after each infusion | Infusions | Participants |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Rate of AEs by Severity and Relationship | The AE rate was the number of AEs over the number of infusions administered. Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. | The SDS comprised all subjects treated with the study drug. | Posted | Number | AEs per infusion | For the duration of the study, up to approximately 29 months | infusions | Participants |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of Acute Serious Bacterial Infections. | The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess. | The Intention-To-Treat (ITT) data set comprised all subjects treated with the study drug | Posted | Number | Infections per subject year | For the duration of the study, up to approximately 29 months | Subject Study Days | Participants |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness. | The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure. | Posted | Median | Full Range | Days | For the duration of the study, up to approximately 29 months. |
|
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| Secondary | Number of Days of Hospitalization. | The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure. | Posted | Median | Full Range | Days | For the duration of the study, up to approximately 29 months |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of Any Infection. | The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class "infections and infestations" and AEs with the preferred term "conjunctivitis". | The ITT data set comprised all subjects treated with the study drug. | Posted | Number | Infections per subject year | For the duration of the study, up to approximately 29 months. | Subject Study Days | Participants |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations. | Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed. | The ITT data set comprised all subjects treated with the study drug for which serum IgG information was available. | Posted | Mean | Full Range | g/L | Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule. |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Clinically Significant Changes in Vital Signs. | Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. | The Safety Data Set (SDS) comprised all subjects treated with the study drug. | Posted | Number | Participants | Before, during, and after each infusion. |
|
|
For the duration of the study, up to approximately 29 months
Only AEs starting at or after the first study drug infusion were included. The SDS comprised all subjects treated with the study drug.
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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 | IgPro10 | A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study. | 11 | 55 | 48 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridial infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Ileostomy closure | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Otitis externa fungal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza-like illness | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | CSL Behring | Use email contact | clinicaltrials@cslbehring.com |
| ID | Term |
|---|---|
| D000361 | Agammaglobulinemia |
| D017099 | IgG Deficiency |
| D017074 | Common Variable Immunodeficiency |
| ID | Term |
|---|---|
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004406 | Dysgammaglobulinemia |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| 16 to < 65 years |
|
| >= 65 years |
|
| Title | Measurements |
|---|---|
|
| OG002 | IgPro10 (> 8 to ≤ 12 mg/kg/Min) | A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (> 8 and ≤ 12 mg/kg/min) for old subjects. |
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| Subject Study Days |
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| Subject Study Days |
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