Trial Outcomes & Findings for Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency (NCT NCT00520494)

NCT ID: NCT00520494

Last Updated: 2013-06-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 18 participants
• Primary outcome timeframe: On Day 12
• Results posted on: 2013-06-20

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency

Baseline characteristics by cohort

Measure	Vivaglobin n=18 Participants 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.
Age Continuous	25.9 years STANDARD_DEVIATION 21.85 • n=5 Participants
Age, Customized 2 to < 12 years	6 participants n=5 Participants
Age, Customized ≥ 12 to ≤ 16 years	2 participants n=5 Participants
Age, Customized > 16 to < 65 years	8 participants n=5 Participants
Age, Customized ≥ 65 years	2 participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12	0.944 proportion of patients Interval 0.7271 to 0.9986

SECONDARY outcome

Timeframe: On Day 19

Population: The ITT data set comprised all patients who were treated with the study drug and completed Day 12.

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19	0.944 proportion of participants Interval 0.7271 to 0.9986

SECONDARY outcome

Timeframe: On Day 26

Population: The ITT data set comprised all patients who were treated with the study drug and completed Day 12.

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26	1.000 proportion of participants Interval 0.8147 to 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Vivaglobin n=17 Participants 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.
IgG Increase (Change From Baseline) on Day 12	3.941 g/L Standard Deviation 0.7466

SECONDARY outcome

Timeframe: 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.

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".

Outcome measures

Measure	Vivaglobin n=24 Infections 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.
Overall Rate of Infections	2.785 infections per patient year Interval 1.785 to 4.144

SECONDARY outcome

Timeframe: On Day 12

Population: The ITT data set comprised all patients who were treated with the study drug and completed Day 12.

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Total Serum IgG Trough Levels on Day 12	7.466 g/L Standard Deviation 1.4592

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Vivaglobin n=17 Participants 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.
Total Serum IgG Trough Levels at Week 25	8.039 g/L Standard Deviation 1.1793

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Vivaglobin n=16 Participants 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.
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 Cytomegalovirus	3.182 IU/mL Standard Deviation 0.8025
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 Tetanus	1.399 IU/mL Standard Deviation 0.3846
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12 Measles	0.743 IU/mL Standard Deviation 0.3681

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Vivaglobin n=15 Participants 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.
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 Cytomegalovirus	3.638 IU/mL Standard Deviation 2.2649
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 Tetanus	1.623 IU/mL Standard Deviation 0.9344
Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25 Measles	0.879 IU/mL Standard Deviation 0.8993

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Vivaglobin n=16 Participants 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.
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Vivaglobin n=15 Participants 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.
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
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 outcome

Timeframe: 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.

Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Use of Antibiotics for Infection Prophylaxis and Treatment Treatment	8 participants
Use of Antibiotics for Infection Prophylaxis and Treatment Prophylaxis	1 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Vivaglobin n=10 Participants 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.
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
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
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
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
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
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
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Vivaglobin n=8 Participants 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.
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
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
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
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
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 0.000
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
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
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
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
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
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
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 39.530
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
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
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 outcome

Timeframe: For the duration of the study, up to approximately 25 weeks

Population: The Safety data set (SDS) comprised all treated patients.

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.

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Number of Patients With Adverse Events (AEs) by Severity and Relatedness Total AEs	14 participants
Number of Patients With Adverse Events (AEs) by Severity and Relatedness Mild AEs	14 participants
Number of Patients With Adverse Events (AEs) by Severity and Relatedness Moderate AEs	5 participants
Number of Patients With Adverse Events (AEs) by Severity and Relatedness Severe AEs	2 participants
Number of Patients With Adverse Events (AEs) by Severity and Relatedness Not related AEs	14 participants
Number of Patients With Adverse Events (AEs) by Severity and Relatedness Possibly related AEs	3 participants
Number of Patients With Adverse Events (AEs) by Severity and Relatedness Probably related AEs	4 participants
Number of Patients With Adverse Events (AEs) by Severity and Relatedness Related AEs	5 participants

SECONDARY outcome

Timeframe: For the duration of the study, up to approximately 25 weeks

Population: The SDS comprised all treated patients.

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.

Outcome measures

Measure	Vivaglobin n=551 Infusions 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.
Rate of AEs by Severity and Relatedness Related AEs	0.074 AEs per infusion
Rate of AEs by Severity and Relatedness Total AEs	0.305 AEs per infusion
Rate of AEs by Severity and Relatedness Mild AEs	0.263 AEs per infusion
Rate of AEs by Severity and Relatedness Moderate AEs	0.034 AEs per infusion
Rate of AEs by Severity and Relatedness Severe AEs	0.007 AEs per infusion
Rate of AEs by Severity and Relatedness Not related AEs	0.200 AEs per infusion
Rate of AEs by Severity and Relatedness Possibly related AEs	0.013 AEs per infusion
Rate of AEs by Severity and Relatedness Probably related AEs	0.018 AEs per infusion

SECONDARY outcome

Timeframe: For the duration of the study, up to approximately 25 weeks

Population: The SDS comprised all treated patients.

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.

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Number of Patients With Local Reactions by Severity and Relatedness Probably related local reactions	1 participants
Number of Patients With Local Reactions by Severity and Relatedness Total local reactions	6 participants
Number of Patients With Local Reactions by Severity and Relatedness Mild local reactions	6 participants
Number of Patients With Local Reactions by Severity and Relatedness Moderate local reactions	0 participants
Number of Patients With Local Reactions by Severity and Relatedness Severe local reactions	0 participants
Number of Patients With Local Reactions by Severity and Relatedness Not related local reactions	1 participants
Number of Patients With Local Reactions by Severity and Relatedness Possibly related local reactions	0 participants
Number of Patients With Local Reactions by Severity and Relatedness Related local reactions	5 participants

SECONDARY outcome

Timeframe: For the duration of the study, up to approximately 25 weeks

Population: The SDS comprised all treated patients.

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.

Outcome measures

Measure	Vivaglobin n=551 infusions 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.
Rate of Local Reactions by Severity and Relatedness Probably related local reactions	0.009 local reactions per infusion
Rate of Local Reactions by Severity and Relatedness Total local reactions	0.076 local reactions per infusion
Rate of Local Reactions by Severity and Relatedness Mild local reactions	0.076 local reactions per infusion
Rate of Local Reactions by Severity and Relatedness Moderate local reactions	0.000 local reactions per infusion
Rate of Local Reactions by Severity and Relatedness Severe local reactions	0.000 local reactions per infusion
Rate of Local Reactions by Severity and Relatedness Not related local reactions	0.004 local reactions per infusion
Rate of Local Reactions by Severity and Relatedness Possibly related local reactions	0.000 local reactions per infusion
Rate of Local Reactions by Severity and Relatedness Related local reactions	0.064 local reactions per infusion

SECONDARY outcome

Timeframe: At Weeks 12 and 25

Population: The SDS comprised all treated patients.

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).

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters	0 participants

SECONDARY outcome

Timeframe: 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.

Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.

Outcome measures

Measure	Vivaglobin n=18 Participants 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.
Number of Patients With Clinically Relevant Changes in Vital Signs	0 participants

Adverse Events

Vivaglobin

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vivaglobin n=18 participants at risk 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.
Nervous system disorders Headache	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Meningitis	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Pyrexia	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Pseudomonal bacteraemia	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Haemophilus infection	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Pseudomonas bronchitis	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.

Other adverse events

Measure	Vivaglobin n=18 participants at risk 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.
Gastrointestinal disorders Nausea	22.2% 4/18 • Number of events 6 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Vomiting	11.1% 2/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Asthenia	16.7% 3/18 • Number of events 3 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Fatigue	11.1% 2/18 • Number of events 3 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Infusion site erythema	11.1% 2/18 • Number of events 7 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Infusion site pain	11.1% 2/18 • Number of events 4 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Injection site bruising	11.1% 2/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Injection site erythema	16.7% 3/18 • Number of events 5 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Injection site pruritus	11.1% 2/18 • Number of events 3 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Injection site swelling	22.2% 4/18 • Number of events 9 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Oedema peripheral	11.1% 2/18 • Number of events 3 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Pyrexia	27.8% 5/18 • Number of events 11 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Nasopharyngitis	11.1% 2/18 • Number of events 5 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Upper respiratory tract infection	16.7% 3/18 • Number of events 4 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 2/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Nervous system disorders Headache	27.8% 5/18 • Number of events 13 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Erythema	11.1% 2/18 • Number of events 3 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Pruritus	11.1% 2/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Urticaria	11.1% 2/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Blood and lymphatic system disorders Haemolysis	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Eye disorders Eye swelling	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Abdominal distension	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Cheilitis	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Enteritis	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Gastritis	5.6% 1/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Oral pain	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Stomach discomfort	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Swollen tongue	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Gastrointestinal disorders Toothache	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Chills	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Feeling hot	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Infusion site pruritus	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Infusion site rash	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Infusion site reaction	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Infusion site swelling	5.6% 1/18 • Number of events 3 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Injection site irritation	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Pain	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
General disorders Tenderness	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Immune system disorders Drug hypersensitivity	5.6% 1/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Candidiasis	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Cystitis	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Ear infection	5.6% 1/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Gastroenteritis	5.6% 1/18 • Number of events 3 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Otitis media	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Respiratory tract infection	5.6% 1/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Infections and infestations Sinusitis	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Injury, poisoning and procedural complications Thoracic vertebral fracture	5.6% 1/18 • Number of events 4 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Investigations Blood creatinine increased	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Metabolism and nutrition disorders Decreased appetite	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 1/18 • Number of events 2 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Nervous system disorders Disturbance in attention	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Nervous system disorders Dizziness	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Nervous system disorders Migraine	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Nervous system disorders Syncope	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Psychiatric disorders Depression	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Psychiatric disorders Nervousness	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Renal and urinary disorders Renal failure acute	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Renal and urinary disorders Renal pain	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • Number of events 4 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 1/18 • Number of events 3 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Respiratory, thoracic and mediastinal disorders Throat tightness	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Dermatitis allergic	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Eczema	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Pruritus generalized	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Rosacea	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.
Skin and subcutaneous tissue disorders Skin swelling	5.6% 1/18 • Number of events 1 • For the duration of the study, up to approximately 25 weeks The SDS comprised all treated patients. Adverse events in "General disorders" were collected under the MedDRA System Organ Class (SOC) General disorders and administration site conditions.

Additional Information

Clinical Trial Disclosure Manager

CSL Behring

Phone: Use email contact

Email: clinicaltrials@cslbehring.com

Results disclosure agreements

• Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER