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This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
Primary immunodeficiency diseases (PIDDs) are genetically determined disorders of the immune system resulting in greatly enhanced susceptibility to infectious disease, autoimmunity and malignancy. As most subjects with PIDDs present with infections, the differential diagnosis and initial investigations for an underlying immune defect are typically guided by the clinical presentation. In subjects with PIDDs, individual infections are not necessarily more severe than those that occur in a normal host. Rather, the clinical features suggestive of an immune defect may be the recurring and/or chronic nature of infections with common pathogens that may result in end organ damage, such as bronchiectasis. Several immune globulin products have already been approved by the FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RI-002 Treatment | Experimental | Drug: RI-002 Dose: 300-800 mg/kg infusion Frequency: Once every 3 to 4 Weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RI-002 | Biological | Immune Globulin Intravenous (IGIV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008)) | The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Infections (Serious and Non-serious) | Up to 1 Year | |
| Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost | Up to 1 year |
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Inclusion Criteria:
To be eligible to participate in this study, the subjects must meet the following criteria:
Exclusion Criteria:
Subjects must be excluded if they meet any of the following criteria:
Have a known hypersensitivity to immunoglobulin or any excipient in RI-002.
Have a history of a severe anaphylactic or anaphylactoid reaction to blood or any blood-derived product.
Have a specific Immunoglobulin A (IgA) deficiency, history of allergic reaction to products containing IgA or has demonstrable antibodies to IgA.
Have uncompensated hemodynamically significant congenital or other heart disease.
Have a medical condition that is known to cause secondary immune deficiency.
Have a significant T-cell deficiency or deficiency of granulocyte number or function.
Have significant renal impairment or have a history of acute renal failure.
Have abnormal liver function.
Be receiving chronic anti-coagulation therapy.
Have a history of deep vein thrombosis (DVT), thrombotic or thrombo-embolic event, or are at increased risk for thrombotic events.
Current daily use of the following medications:
Administration of a hyperimmune or specialty high titer immunoglobulin product.
Have uncontrollable arterial hypertension.
Have a history of hemolysis or positive Coombs test while undergoing treatment with IGIV therapy.
Be morbidly obese as indicated by a Body Mass Index (BMI) ≥ 40
Have received any blood product (other than Immunoglobulin G) within 3 months prior to screening.
Have received any Respiratory Syncytial Virus (RSV) specific products, including palivizumab (Synagis®) within 3 months prior to screening.
Have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
Have any condition or abnormal laboratory assessment judged by the investigator to preclude participation in the study.
Are currently pregnant or nursing.
Have hepatitis A, B, or C.
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| Name | Affiliation | Role |
|---|---|---|
| James Mond, M.D., Ph.D. | ADMA Biologics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMMUNOe Health Centers | Cenntennial | Colorado | 80112 | United States | ||
| Allergy Associates of the Palm Beaches, P.A. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RI-002 Treatment | Drug: RI-002 Dose: 300-800 mg/kg IV infusion Frequency: Every 3 or 4 weeks Initial dose selection based on prior IGIV regimen, doses adjusted during study to maintain trough Immunoglobulin G (IgG) concentration of 500 mg/dL or greater according to investigator decision. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year | Up to 1 year |
| Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits | Up to 1 year |
| Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year | Up to 1 year |
| Time to Resolution of Infections - Duration Per Infection | Up to 1 year |
| Time to Resolution of Infections - Infection Days Per Subject | Up to 1 year |
| Number of Hospitalizations Due to Infections | Up to 1 year |
| Number of Hospitalizations Due to Infections - Per Subject-Year | Up to 1 year |
| Days of Hospitalization Due to Infections | Up to 1 year |
| Days of Hospitalization Due to Infections - Per Subject-Year | Up to 1 year |
| Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) | Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined | Up to 1 year |
| Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year | Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002 | Up to 1 year |
| Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections | The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded) | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - IgG | Summary of trough total IgG concentration prior to specified infusion | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B | Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV) | Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV) | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Tetanus | Summary of trough antibody concentrations prior to specified infusion for Tetanus | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1 | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3 | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4 | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5 | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14 | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F | Up to 1 year |
| Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F | Up to 1 year |
| North Palm Beach |
| Florida |
| 33408 |
| United States |
| Family Allergy Center, PC | Atlanta | Georgia | 30342 | United States |
| The South Bend Clinic, LLP | South Bend | Indiana | 46617 | United States |
| Asthma & Immunology Associates | Omaha | Nebraska | 68124 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Dallas Immunology Research | Dallas | Texas | 75230 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Baylor Texas Children's Hospital | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RI-002 Treatment | Drug: RI-002 Dose: 300-800 mg/kg infusion RI-002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| PIDD Type | Primary PIDD diagnosis | Number | 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 | Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008)) | The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency. | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | SBIs/subject/year | One year |
|
|
| ||||||||||||||||||||||||||
| Secondary | Incidence of All Infections (Serious and Non-serious) | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | events per subject-year | Up to 1 Year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Days | Up to 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Days per subject-year | Up to 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Number of Visits | Up to 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Number of Visits per subject-year | Up to 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Time to Resolution of Infections - Duration Per Infection | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Mean | Standard Deviation | Days | Up to 1 year |
|
|
| ||||||||||||||||||||||||||
| Secondary | Time to Resolution of Infections - Infection Days Per Subject | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Mean | Standard Deviation | Days per subject | Up to 1 year |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Hospitalizations Due to Infections | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Number of hospitalizations | Up to 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Hospitalizations Due to Infections - Per Subject-Year | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Hospitalizations per subject-year | Up to 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Days of Hospitalization Due to Infections | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Days | Up to 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Days of Hospitalization Due to Infections - Per Subject-Year | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Days per subject-year | Up to 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) | Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Days | Up to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year | Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002 | Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Days per subject-year | Up to 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections | The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded) | Posted | Number | Linear Correlation Coefficients | Up to 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - IgG | Summary of trough total IgG concentration prior to specified infusion | Posted | Mean | Standard Error | mg/dL | Up to 1 year |
|
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B | Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV) | Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV) | Number available for analysis varied by infusion; 51-56 subjects | Posted | Mean | Standard Error | titer | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Tetanus | Summary of trough antibody concentrations prior to specified infusion for Tetanus | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | IU/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1 | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3 | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4 | Number available for analysis varied by infusion; 53-58 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5 | Number available for analysis varied by infusion; 52-58 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F | Number available for analysis varied by infusion; 53-57 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14 | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14 | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A | Number available for analysis varied by infusion; 51-54 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F | Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F | Number available for analysis varied by infusion; 53-59 subjects | Posted | Mean | Standard Error | ug/mL | Up to 1 year |
|
| ||||||||||||||||||||||||||
| Post-Hoc | Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment | Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection | Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Days | Up to 1 year |
|
| |||||||||||||||||||||||||||
| Post-Hoc | Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment - Per Subject-Year | Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection | Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | Days per subject-year | Up to 1 year |
|
| |||||||||||||||||||||||||||
| Post-Hoc | Number of Participants With No Days Lost From Work/School/Daycare Due to Infections and Their Treatment | Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection. Presenting the number of subjects with no (0) days lost from work/school/daycare due to infection | Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002 | Posted | Number | participants | Up to 1 year |
|
|
Subjects were treated with RI-002 every 3 or 4-weeks for up to 12 months, with Adverse Events reported from time of consent through the last study follow-up
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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 | RI-002 Treatment | Drug: RI-002 Dose: 300-800 mg/kg infusion RI-002 | 2 | 59 | 58 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative wound infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cough | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
Following the first publication (sponsor coordinated), the Institution/PI may publish data or results from the study, if the material is reviewed by the sponsor at least 60 days prior to the proposed deadline; sponsor may remove any information considered confidential other than study data and results. If a multi-center publication is not submitted within 24 months after conclusion of the study at all sites, the Institution/PI may publish the study results following review by the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jimmy Mond, M.D., Ph.D | ADMA Biologics | 201-478-5552 | jmond@admabio.com |
| 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 |
|---|---|
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Antibody Deficiencies |
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| Other |
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| Number of Infections (All) per subject-year |
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| Number of Serious Infections per subject-year |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Total days of antibiotic use COMBINED |
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| Total days of antibiotic use for INFECTION |
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| Total days of antibiotic use for PROPHYLAXIS |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Forward analysis |
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| Backward analysis |
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| Infusion 1 (n=59) |
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| Infusion 2 (n=57) |
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| Infusion 3 (n=55) |
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| Infusion 4 (n=56) |
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| Infusion 5 (n=55) |
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| Infusion 6 (n=56) |
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| Infusion 7 (n=55) |
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| Infusion 8 (n=56) |
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| Infusion 9 (n=56) |
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| Infusion 10 (n=54) |
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| Infusion 11 (n=55) |
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| Infusion 12 (n=54) |
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| Infusion 13 (n=53) |
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| Infusion 14 (3-week cycle only) (n=16) |
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| Infusion 15 (3-week cycle only) (n=16) |
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| Infusion 16 (3-week cycle only) (n=16) |
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| Infusion 17 (3-week cycle only) (n=16) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=56) |
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| Infusion 8 (n=56) |
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| Infusion 12 (n=54) |
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| End of Study (Infusion 13 / 17) (n=53) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=56) |
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| Infusion 4 (n=54) |
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| Infusion 8 (n=54) |
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| Infusion 12 (n=52) |
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| End of Study (Infusion 13 / 17) (n=51) |
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| Title | Denominators | Categories |
|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=56) |
| |||||
| Infusion 8 (n=56) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=55) |
| |||||
| Infusion 8 (n=56) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=56) |
| |||||
| Infusion 8 (n=56) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=58) |
| |||||
| Infusion 4 (n=56) |
| |||||
| Infusion 8 (n=55) |
| |||||
| Infusion 12 (n=53) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=58) |
| |||||
| Infusion 4 (n=54) |
| |||||
| Infusion 8 (n=55) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=52) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=56) |
| |||||
| Infusion 8 (n=56) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=57) |
| |||||
| Infusion 4 (n=55) |
| |||||
| Infusion 8 (n=55) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=56) |
| |||||
| Infusion 8 (n=56) |
| |||||
| Infusion 12 (n=53) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=56) |
| |||||
| Infusion 8 (n=56) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=56) |
| |||||
| Infusion 8 (n=55) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=53) |
| |||||
| Infusion 4 (n=52) |
| |||||
| Infusion 8 (n=54) |
| |||||
| Infusion 12 (n=51) |
| |||||
| End of Study (Infusion 13 / 17) (n=52) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=55) |
| |||||
| Infusion 8 (n=56) |
| |||||
| Infusion 12 (n=53) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Infusion 1 (n=59) |
| |||||
| Infusion 4 (n=55) |
| |||||
| Infusion 8 (n=56) |
| |||||
| Infusion 12 (n=54) |
| |||||
| End of Study (Infusion 13 / 17) (n=53) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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