Agammaglobulinemia, Common Variable Immunodeficiency
Conditions
Keywords
Previously Untreated Patient (PUP), Primary Immunodeficiency (PID), CVID, XLA, Subcutaneous immunoglobulin (SCIG), IgG trough level, Quality of life, Common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA)
Brief summary
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.
Interventions
DRUGVivaglobin
Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.
Sponsors
CSL Behring
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Written informed consent, age-adapted * Male or female aged 1 to 70 years * Diagnosis of primary humoral immunodeficiency * No prior immunoglobulin substitution therapy * IgG level of \<5 g/L at screening * Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening Key
Exclusion criteria
* Evidence of serious infection between screening and first treatment * Bleeding disorders that require medical treatments * Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity * Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 | On Day 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26 | On Day 26 | — |
| IgG Increase (Change From Baseline) on Day 12 | Baseline to Day 12 | — |
| Overall Rate of Infections | For the duration of the study, up to approximately 25 weeks | Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class infections and infestations. |
| Total Serum IgG Trough Levels on Day 12 | On Day 12 | — |
| Total Serum IgG Trough Levels at Week 25 | At Week 25 | — |
| Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 | On Day 12 | — |
| Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 | At Week 25 | — |
| Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12 | On Day 12 | — |
| Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25 | At Week 25 | — |
| Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19 | On Day 19 | — |
| Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | At study completion, approximately Week 25 | The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state. |
| Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | At study completion, approximately Week 25 | The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state. |
| Number of Patients With Adverse Events (AEs) by Severity and Relatedness | For the duration of the study, up to approximately 25 weeks | Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. |
| Rate of AEs by Severity and Relatedness | For the duration of the study, up to approximately 25 weeks | The rate was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. |
| Number of Patients With Local Reactions by Severity and Relatedness | For the duration of the study, up to approximately 25 weeks | Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. |
| Rate of Local Reactions by Severity and Relatedness | For the duration of the study, up to approximately 25 weeks | The rate was the number of local reactions over the number of infusions administered. Local reactions included: * infusion site: erythema, pain, pruritus, rash, reaction, swelling; * injection site: bruising, erythema, irritation, pruritus, swelling; * edema peripheral; * tenderness; * erythema; * pruritus; and * skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping. |
| Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters | At Weeks 12 and 25 | Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25). |
| Number of Patients With Clinically Relevant Changes in Vital Signs | At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25) | Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature. |
| Use of Antibiotics for Infection Prophylaxis and Treatment | For the duration of the study, up to approximately 25 weeks | Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code. |
Countries
Canada, Germany, Italy, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vivaglobin Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Vivaglobin |
|---|---|
| Age Continuous | 25.9 years STANDARD_DEVIATION 21.85 |
| Age, Customized ≥ 12 to ≤ 16 years | 2 participants |
| Age, Customized > 16 to < 65 years | 8 participants |
| Age, Customized 2 to < 12 years | 6 participants |
| Age, Customized ≥ 65 years | 2 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 18 |
| serious Total, serious adverse events | 2 / 18 |
Outcome results
Primary
Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12
Time frame: On Day 12
Population: The intention-to-treat (ITT) data set comprised all patients who were treated with the study drug and completed Day 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaglobin | Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12 | 0.944 proportion of patients |
Secondary
IgG Increase (Change From Baseline) on Day 12
Time frame: Baseline to Day 12
Population: The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which IgG results, as required for the analysis, were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivaglobin | IgG Increase (Change From Baseline) on Day 12 | 3.941 g/L | Standard Deviation 0.7466 |
Secondary
Number of Patients With Adverse Events (AEs) by Severity and Relatedness
Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
Time frame: For the duration of the study, up to approximately 25 weeks
Population: The Safety data set (SDS) comprised all treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vivaglobin | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Not related AEs | 14 participants |
| Vivaglobin | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Possibly related AEs | 3 participants |
| Vivaglobin | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Total AEs | 14 participants |
| Vivaglobin | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Mild AEs | 14 participants |
| Vivaglobin | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Moderate AEs | 5 participants |
| Vivaglobin | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Severe AEs | 2 participants |
| Vivaglobin | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Probably related AEs | 4 participants |
| Vivaglobin | Number of Patients With Adverse Events (AEs) by Severity and Relatedness | Related AEs | 5 participants |
Secondary
Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters
Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25).
Time frame: At Weeks 12 and 25
Population: The SDS comprised all treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaglobin | Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters | 0 participants |
Secondary
Number of Patients With Clinically Relevant Changes in Vital Signs
Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
Time frame: At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25)
Population: The SDS comprised all treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaglobin | Number of Patients With Clinically Relevant Changes in Vital Signs | 0 participants |
Secondary
Number of Patients With Local Reactions by Severity and Relatedness
Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
Time frame: For the duration of the study, up to approximately 25 weeks
Population: The SDS comprised all treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vivaglobin | Number of Patients With Local Reactions by Severity and Relatedness | Total local reactions | 6 participants |
| Vivaglobin | Number of Patients With Local Reactions by Severity and Relatedness | Mild local reactions | 6 participants |
| Vivaglobin | Number of Patients With Local Reactions by Severity and Relatedness | Moderate local reactions | 0 participants |
| Vivaglobin | Number of Patients With Local Reactions by Severity and Relatedness | Severe local reactions | 0 participants |
| Vivaglobin | Number of Patients With Local Reactions by Severity and Relatedness | Not related local reactions | 1 participants |
| Vivaglobin | Number of Patients With Local Reactions by Severity and Relatedness | Possibly related local reactions | 0 participants |
| Vivaglobin | Number of Patients With Local Reactions by Severity and Relatedness | Probably related local reactions | 1 participants |
| Vivaglobin | Number of Patients With Local Reactions by Severity and Relatedness | Related local reactions | 5 participants |
Secondary
Overall Rate of Infections
Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days. Infections were classified as all AEs with the system organ class infections and infestations.
Time frame: For the duration of the study, up to approximately 25 weeks
Population: The ITT data set comprised all patients who were treated with the study drug and completed Day 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaglobin | Overall Rate of Infections | 2.785 infections per patient year |
Secondary
Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19
Time frame: On Day 19
Population: The ITT data set comprised all patients who were treated with the study drug and completed Day 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaglobin | Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19 | 0.944 proportion of participants |
Secondary
Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26
Time frame: On Day 26
Population: The ITT data set comprised all patients who were treated with the study drug and completed Day 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivaglobin | Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26 | 1.000 proportion of participants |
Secondary
Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)
The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.
Time frame: At study completion, approximately Week 25
Population: The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the SF-36 questionnaire were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivaglobin | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | Social functioning | 80.00 units on a scale | Standard Deviation 30.162 |
| Vivaglobin | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | Role-emotional | 79.17 units on a scale | Standard Deviation 33.158 |
| Vivaglobin | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | Mental health | 74.50 units on a scale | Standard Deviation 23.268 |
| Vivaglobin | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | Physical functioning | 75.50 units on a scale | Standard Deviation 33.948 |
| Vivaglobin | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | Role-physical | 70.63 units on a scale | Standard Deviation 37.038 |
| Vivaglobin | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | Bodily pain | 65.60 units on a scale | Standard Deviation 37.262 |
| Vivaglobin | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | General health | 56.40 units on a scale | Standard Deviation 27.097 |
| Vivaglobin | Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years) | Vitality | 54.40 units on a scale | Standard Deviation 28.575 |
Secondary
Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)
The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state.
Time frame: At study completion, approximately Week 25
Population: The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the CHQ-PF50 questionnaire were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Global health | 82.50 units on a scale | Standard Deviation 15.353 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | General health perceptions | 61.66 units on a scale | Standard Deviation 22.791 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Parental impact - time | 88.90 units on a scale | Standard Deviation 15.698 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Physical functioning | 97.91 units on a scale | Standard Deviation 4.135 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Role/social limitations - emotional/behavioral | 100.00 units on a scale | Standard Deviation 0 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Role/social limitations - physical | 95.84 units on a scale | Standard Deviation 11.773 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Bodily pain | 82.50 units on a scale | Standard Deviation 24.349 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Behavior | 74.06 units on a scale | Standard Deviation 13.899 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Global behavior | 75.63 units on a scale | Standard Deviation 12.939 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Mental health | 83.13 units on a scale | Standard Deviation 13.871 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Self esteem | 90.64 units on a scale | Standard Deviation 6.948 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Change in health | 84.38 units on a scale | Standard Deviation 18.601 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Parental impact - emotional | 64.58 units on a scale | Standard Deviation 39.53 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Family activities | 86.98 units on a scale | Standard Deviation 17.457 |
| Vivaglobin | Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years) | Family cohesion | 77.50 units on a scale | Standard Deviation 15.353 |
Secondary
Rate of AEs by Severity and Relatedness
The rate was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
Time frame: For the duration of the study, up to approximately 25 weeks
Population: The SDS comprised all treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vivaglobin | Rate of AEs by Severity and Relatedness | Not related AEs | 0.200 AEs per infusion |
| Vivaglobin | Rate of AEs by Severity and Relatedness | Possibly related AEs | 0.013 AEs per infusion |
| Vivaglobin | Rate of AEs by Severity and Relatedness | Related AEs | 0.074 AEs per infusion |
| Vivaglobin | Rate of AEs by Severity and Relatedness | Total AEs | 0.305 AEs per infusion |
| Vivaglobin | Rate of AEs by Severity and Relatedness | Mild AEs | 0.263 AEs per infusion |
| Vivaglobin | Rate of AEs by Severity and Relatedness | Moderate AEs | 0.034 AEs per infusion |
| Vivaglobin | Rate of AEs by Severity and Relatedness | Severe AEs | 0.007 AEs per infusion |
| Vivaglobin | Rate of AEs by Severity and Relatedness | Probably related AEs | 0.018 AEs per infusion |
Secondary
Rate of Local Reactions by Severity and Relatedness
The rate was the number of local reactions over the number of infusions administered. Local reactions included: * infusion site: erythema, pain, pruritus, rash, reaction, swelling; * injection site: bruising, erythema, irritation, pruritus, swelling; * edema peripheral; * tenderness; * erythema; * pruritus; and * skin swelling. Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping.
Time frame: For the duration of the study, up to approximately 25 weeks
Population: The SDS comprised all treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vivaglobin | Rate of Local Reactions by Severity and Relatedness | Total local reactions | 0.076 local reactions per infusion |
| Vivaglobin | Rate of Local Reactions by Severity and Relatedness | Mild local reactions | 0.076 local reactions per infusion |
| Vivaglobin | Rate of Local Reactions by Severity and Relatedness | Moderate local reactions | 0.000 local reactions per infusion |
| Vivaglobin | Rate of Local Reactions by Severity and Relatedness | Severe local reactions | 0.000 local reactions per infusion |
| Vivaglobin | Rate of Local Reactions by Severity and Relatedness | Not related local reactions | 0.004 local reactions per infusion |
| Vivaglobin | Rate of Local Reactions by Severity and Relatedness | Possibly related local reactions | 0.000 local reactions per infusion |
| Vivaglobin | Rate of Local Reactions by Severity and Relatedness | Probably related local reactions | 0.009 local reactions per infusion |
| Vivaglobin | Rate of Local Reactions by Severity and Relatedness | Related local reactions | 0.064 local reactions per infusion |
Secondary
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25
Time frame: At Week 25
Population: The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivaglobin | Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 | Cytomegalovirus | 3.638 IU/mL | Standard Deviation 2.2649 |
| Vivaglobin | Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 | Tetanus | 1.623 IU/mL | Standard Deviation 0.9344 |
| Vivaglobin | Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 | Measles | 0.879 IU/mL | Standard Deviation 0.8993 |
Secondary
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12
Time frame: On Day 12
Population: The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivaglobin | Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 | Cytomegalovirus | 3.182 IU/mL | Standard Deviation 0.8025 |
| Vivaglobin | Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 | Tetanus | 1.399 IU/mL | Standard Deviation 0.3846 |
| Vivaglobin | Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 | Measles | 0.743 IU/mL | Standard Deviation 0.3681 |
Secondary
Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25
Time frame: At Week 25
Population: The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivaglobin | Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25 | H. influenzae | 1.671 mg/L | Standard Deviation 0.7796 |
| Vivaglobin | Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25 | S. pneumoniae | 26.985 mg/L | Standard Deviation 22.2594 |
Secondary
Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12
Time frame: On Day 12
Population: The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vivaglobin | Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12 | S. pneumoniae | 18.588 mg/L | Standard Deviation 9.4659 |
| Vivaglobin | Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12 | H. influenzae | 1.023 mg/L | Standard Deviation 0.3141 |
Secondary
Total Serum IgG Trough Levels at Week 25
Time frame: At Week 25
Population: The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 total serum IgG results were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivaglobin | Total Serum IgG Trough Levels at Week 25 | 8.039 g/L | Standard Deviation 1.1793 |
Secondary
Total Serum IgG Trough Levels on Day 12
Time frame: On Day 12
Population: The ITT data set comprised all patients who were treated with the study drug and completed Day 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivaglobin | Total Serum IgG Trough Levels on Day 12 | 7.466 g/L | Standard Deviation 1.4592 |
Secondary
Use of Antibiotics for Infection Prophylaxis and Treatment
Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.
Time frame: For the duration of the study, up to approximately 25 weeks
Population: The ITT data set comprised all patients who were treated with the study drug and completed Day 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vivaglobin | Use of Antibiotics for Infection Prophylaxis and Treatment | Prophylaxis | 1 participants |
| Vivaglobin | Use of Antibiotics for Infection Prophylaxis and Treatment | Treatment | 8 participants |