Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1473 | Other Identifier | CSL Behring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro20 | Experimental | The IgPro20 dose will be the same as in the previous pivotal study ZLB04_009CR (NCT00419341) infused subcutaneously weekly or twice a week (in the latter case, half of a weekly dose will be used) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgPro20 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population) | 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. | For the duration of the study, up to approximately 104 weeks |
| Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population) | 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. | For the duration of the study, up to approximately 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | For the duration of the study, up to approximately 104 weeks |
| Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Program Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact CSL Behring for facility details | Centennial | Colorado | 80112 | United States | ||
| Contact CSL Behring for facility details |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24412910 | Result | Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL. Long-term efficacy, safety, and tolerability of Hizentra(R) for treatment of primary immunodeficiency disease. Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. Epub 2013 Oct 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IgPro20 | A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IgPro20 | A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population) | 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) population comprised all subjects treated with study medication during any study period. | Posted | Number | infections per subject year | For the duration of the study, up to approximately 104 weeks | Subject Study Days | Participants |
|
From the time of informed consent until study completion, up to approximately 121 weeks
The All-Treated (AT) safety population comprised all subjects treated with the study medication during any study period
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IgPro20 | A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA (13.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | CSL Behring | Use email contact | clinicaltrials@cslbehring.com |
Not provided
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C558471 | Hizentra |
| D007074 | Immunoglobulin G |
| D011392 | Proline |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Mean of individual median total IgG trough concentration. |
| Before infusion at Weeks 1, 24, 48, 72, and 96 |
| Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection | For the duration of the study, up to approximately 104 weeks |
| Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection | The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | For the duration of the study, up to approximately 104 weeks |
| Number of Days of Hospitalization Due to Infection | For the duration of the study, up to approximately 104 weeks |
| Annualized Rate of Hospitalization Due to Infection | The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | For the duration of the study, up to approximately 104 weeks |
| Use of Antibiotics for Infection Prophylaxis and Treatment | Annualized rate of days with antibiotics for infection prophylaxis and treatment. | For the duration of the study, up to approximately 104 weeks |
| Rate of All AEs by Relatedness and Severity | The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. | For the duration of the study, up to approximately 104 weeks |
| Relatedness and Severity of All AEs (Percentage of Total AEs) | At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. | For the duration of the study, up to approximately 104 weeks |
| Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion | AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion. | Within 24 or 72 hours after each infusion |
| Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion | The rate of AEs was the number of AEs over the number of infusions administered. AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion. | Within 24 or 72 hours after each infusion |
| Number of Subjects Reporting Mild, Moderate, or Severe Local AEs | In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. | For the duration of the study, up to approximately 104 weeks |
| Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs | Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature. | At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96 |
| Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters | Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters. | At Week 1, and study completion (approximately 104 weeks) |
| Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers | Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19. | At Week 1, and study completion (approximately 104 weeks) |
| North Palm Beach |
| Florida |
| 33408 |
| United States |
| Contact CSL Behring for facility details | Indianapolis | Indiana | 46202 | United States |
| Contact CSL Behring for facility details | Dallas | Texas | 75230 | United States |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | The ITT population comprised all subjects treated with study medication during any study period. | Posted | Number | infections per subject year | For the duration of the study, up to approximately 104 weeks | Subject Study Days | Participants |
|
|
|
| Primary | Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population) | 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 Per-Protocol Efficacy population comprised all subjects who completed at least 48 weeks of the efficacy period that started with the first IgPro20 dose in this study. | Posted | Number | infections per subject year | For the duration of the study, up to approximately 104 weeks | Subject Study Days | Participants |
|
|
|
| Secondary | Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations | Mean of individual median total IgG trough concentration. | The ITT population comprised all subjects treated with study medication during any study period. | Posted | Mean | Standard Deviation | g/L | Before infusion at Weeks 1, 24, 48, 72, and 96 |
|
|
|
| Secondary | Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection | The ITT population comprised all subjects treated with study medication during any study period. | Posted | Mean | Standard Deviation | days | For the duration of the study, up to approximately 104 weeks |
|
|
|
| Secondary | Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection | The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | The ITT population comprised all subjects treated with study medication during any study period. | Posted | Number | days per subject year | For the duration of the study, up to approximately 104 weeks | Subject Study Days | Participants |
|
|
|
| Secondary | Number of Days of Hospitalization Due to Infection | The ITT population comprised all subjects treated with study medication during any study period. | Posted | Mean | Standard Deviation | days | For the duration of the study, up to approximately 104 weeks |
|
|
|
| Secondary | Annualized Rate of Hospitalization Due to Infection | The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | The ITT population comprised all subjects treated with study medication during any study period. | Posted | Number | days per subject year | For the duration of the study, up to approximately 104 weeks | Subject Study Days | Participants |
|
|
|
| Secondary | Use of Antibiotics for Infection Prophylaxis and Treatment | Annualized rate of days with antibiotics for infection prophylaxis and treatment. | The ITT population comprised all subjects treated with study medication during any study period. | Posted | Number | days per subject year | For the duration of the study, up to approximately 104 weeks | Subject Exposure Days | Participants |
|
|
|
| Secondary | Rate of All AEs by Relatedness and Severity | The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. | The All-Treated (AT) safety population comprised all subjects treated with the study medication during any study period. | Posted | Number | AEs per infusion | For the duration of the study, up to approximately 104 weeks | Infusions | Participants |
|
|
|
| Secondary | Relatedness and Severity of All AEs (Percentage of Total AEs) | At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. | The AT safety population comprised all subjects treated with the study medication during any study period. | Posted | Number | percentage of total AEs | For the duration of the study, up to approximately 104 weeks | AEs | Participants |
|
|
|
| Secondary | Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion | AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion. | The AT safety population comprised all subjects treated with the study medication during any study period. | Posted | Number | participants | Within 24 or 72 hours after each infusion |
|
|
|
| Secondary | Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion | The rate of AEs was the number of AEs over the number of infusions administered. AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion. | The AT safety population comprised all subjects treated with the study medication during any study period. | Posted | Number | AEs per infusion | Within 24 or 72 hours after each infusion | Infusions | Participants |
|
|
|
| Secondary | Number of Subjects Reporting Mild, Moderate, or Severe Local AEs | In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. | The AT safety population comprised all subjects treated with the study medication during any study period. | Posted | Number | participants | For the duration of the study, up to approximately 104 weeks |
|
|
|
| Secondary | Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs | Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature. | The AT safety population comprised all subjects treated with the study medication during any study period. | Posted | Number | participants | At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96 |
|
|
|
| Secondary | Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters | Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters. | The AT safety population comprised all subjects treated with the study medication during any study period. | Posted | Number | participants | At Week 1, and study completion (approximately 104 weeks) |
|
|
|
| Secondary | Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers | Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19. | The AT safety population comprised all subjects treated with the study medication during any study period. | Posted | Number | participants | At Week 1, and study completion (approximately 104 weeks) |
|
|
|
| 4 |
| 21 |
| 21 |
| 21 |
| Pneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Infusion site reaction | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Influenza-like illness | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
CSL agreements 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 requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| Title | Measurements |
|---|---|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|
|
| Severe |
|