Trial Outcomes & Findings for Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (NCT NCT00542997)
NCT ID: NCT00542997
Last Updated: 2011-09-01
Results Overview
Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject's median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.
COMPLETED
PHASE3
51 participants
Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)
2011-09-01
Participant Flow
This multinational study enrolled subjects at 15 of the participating study centers in Europe.
Screening took place 1 to 4 weeks prior to the first IgPro20 infusion.
Participant milestones
| Measure |
IgPro20 (All Treated)
All subjects receiving at least 1 infusion of IgPro20
|
|---|---|
|
Wash in / Wash Out Period
STARTED
|
51
|
|
Wash in / Wash Out Period
COMPLETED
|
46
|
|
Wash in / Wash Out Period
NOT COMPLETED
|
5
|
|
Efficacy Period
STARTED
|
46
|
|
Efficacy Period
COMPLETED
|
43
|
|
Efficacy Period
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
IgPro20 (All Treated)
All subjects receiving at least 1 infusion of IgPro20
|
|---|---|
|
Wash in / Wash Out Period
Withdrawal by Subject
|
2
|
|
Wash in / Wash Out Period
Adverse Event
|
3
|
|
Efficacy Period
Adverse Event
|
3
|
Baseline Characteristics
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
Baseline characteristics by cohort
| Measure |
IgPro20 (All Treated)
n=51 Participants
All subjects enrolled and treated with subcutaneous infusion of IgPro20
|
|---|---|
|
Age Continuous
|
22.6 years
STANDARD_DEVIATION 16.02 • n=93 Participants
|
|
Age, Customized
2 to < 12 years
|
18 Participants
n=93 Participants
|
|
Age, Customized
12 to < 16 years
|
5 Participants
n=93 Participants
|
|
Age, Customized
16 to < 65 years
|
28 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=93 Participants
|
|
Type of Primary Immunodeficiency
Common variable immunodeficiency (CVID)
|
30 Participants
n=93 Participants
|
|
Type of Primary Immunodeficiency
X-linked agammaglobulinemia (XLA)
|
20 Participants
n=93 Participants
|
|
Type of Primary Immunodeficiency
Autosomal recessive agammaglobulinemia (ARAG)
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)Population: Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12). For 2 subjects in the ITT population, the pre-study treatment IgG trough levels were not available.
Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject's median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.
Outcome measures
| Measure |
IgPro20
n=46 Participants
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
n=44 Participants
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Total Serum IgG Trough Levels
|
8.10 g/L
Standard Deviation 1.44
|
7.49 g/L
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Efficacy period: week 12 to week 40 after study start or to the completion visitPopulation: Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).
Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters. The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=8745 Subject Days
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)
|
0 SBIs/subject/year
|
—
|
SECONDARY outcome
Timeframe: Efficacy period: week 12 to week 40 after study start or to the completion visitPopulation: Per Protocol Efficacy (PPE) population analysis. The PPE population included all subjects who completed the 28-week efficacy period according to protocol.
Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters. The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the PPE population and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=6729 Subject Days
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)
|
0 SBIs/subject/year
|
—
|
SECONDARY outcome
Timeframe: Efficacy period: week 12 to week 40 after study start or to the completion visitPopulation: Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).
The annual rate of episodes was calculated based on the total number of any infection type and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=8745 Subject Days
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Annual Rate of Infection Episodes
|
5.18 episodes/subject/year
Interval 4.31 to 6.17
|
—
|
SECONDARY outcome
Timeframe: Efficacy period: week 12 to week 40 after study start or to the completion visitPopulation: Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).
The annual rate was calculated based on the total number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=9033 Subject Days
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
|
8.00 days/subject/year
|
—
|
SECONDARY outcome
Timeframe: Efficacy period: week 12 to week 40 after study start or to the completion visitPopulation: ITT population analysis. The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit).
The annual rate was calculated based on the total number of days of hospitalization due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=9033 Subject Days
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Annual Rate of the Number of Days of Hospitalization Due to Infections
|
3.48 days/subject/year
|
—
|
SECONDARY outcome
Timeframe: Efficacy period: week 12 to week 40 after study start or to the completion visitPopulation: ITT population analysis. The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit).
The annual rate was calculated based on the total number of days of antibiotic use in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.
Outcome measures
| Measure |
IgPro20
n=8745 Subject Days
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment
|
72.75 days/subject/year
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 28 (±1week)Population: Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.
Outcome measures
| Measure |
IgPro20
n=23 Participants
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Maximum Concentration (Cmax) of Total Serum IgG
|
8.26 g/L
Standard Deviation 1.25
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 28 (±1week)Population: Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.
Outcome measures
| Measure |
IgPro20
n=23 Participants
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Timepoint of Maximum Concentration (Tmax) of Total Serum IgG
|
2.06 day
Interval 0.94 to 6.92
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 28 (±1week)Population: Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.
AUC\_last = Area under the concentration-time curve until last measured concentration.
Outcome measures
| Measure |
IgPro20
n=23 Participants
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG
|
53.70 day x g/L
Standard Deviation 9.16
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 28 (±1week)Population: Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population. 7 subjects were missing data for AUCτ.
AUCτ = Area under the concentration-time curve during regular dosing interval;
Outcome measures
| Measure |
IgPro20
n=16 Participants
Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
|
Pre-study IgG Treatment
Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
|
|---|---|---|
|
Area Under the Concentration-Time Curve (AUCτ) of Total Serum IgG
|
53.61 day x g/L
Standard Deviation 9.98
|
—
|
Adverse Events
IgPro20 (All Treated)
Serious adverse events
| Measure |
IgPro20 (All Treated)
n=51 participants at risk
All subjects receiving at least 1 infusion of IgPro20
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • Number of events 1 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • Number of events 2 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Pyrexia
|
2.0%
1/51 • Number of events 1 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Bronchiolitis
|
2.0%
1/51 • Number of events 1 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Appendicitis
|
2.0%
1/51 • Number of events 1 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Nervous system disorders
Sciatica
|
2.0%
1/51 • Number of events 1 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
Other adverse events
| Measure |
IgPro20 (All Treated)
n=51 participants at risk
All subjects receiving at least 1 infusion of IgPro20
|
|---|---|
|
Infections and infestations
Bronchitis
|
31.4%
16/51 • Number of events 26 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Pyrexia
|
27.5%
14/51 • Number of events 14 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.5%
13/51 • Number of events 26 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Nervous system disorders
Headache
|
25.5%
13/51 • Number of events 54 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Nasopharyngitis
|
23.5%
12/51 • Number of events 20 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.5%
12/51 • Number of events 17 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.6%
10/51 • Number of events 16 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Injection site reaction
|
17.6%
9/51 • Number of events 16 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Sinusitis
|
13.7%
7/51 • Number of events 11 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Injection site pain
|
11.8%
6/51 • Number of events 8 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Infusion site pain
|
9.8%
5/51 • Number of events 10 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Injection site pruritus
|
9.8%
5/51 • Number of events 17 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
5/51 • Number of events 5 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Injection site swelling
|
7.8%
4/51 • Number of events 6 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
4/51 • Number of events 12 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
4/51 • Number of events 14 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Respiratory tract infection
|
7.8%
4/51 • Number of events 5 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
4/51 • Number of events 5 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
3/51 • Number of events 4 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Acute sinusitis
|
5.9%
3/51 • Number of events 4 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
3/51 • Number of events 3 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
3/51 • Number of events 3 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Eye disorders
Conjunctivitis
|
5.9%
3/51 • Number of events 6 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
3/51 • Number of events 5 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Fatigue
|
5.9%
3/51 • Number of events 6 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Gastroenteritis
|
5.9%
3/51 • Number of events 3 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Infusion site haematoma
|
5.9%
3/51 • Number of events 3 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
General disorders
Injection site erythema
|
5.9%
3/51 • Number of events 3 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
3/51 • Number of events 3 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Oral herpes
|
5.9%
3/51 • Number of events 3 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
|
Infections and infestations
Rhinitis
|
5.9%
3/51 • Number of events 4 • The observation period for adverse events was from the time the subjects had given informed consent until they had the final examination (completion visit up to 40 weeks) or extended when serious adverse events were reported.
A total of 1831 infusions of IgPro20 were administered to 51 subjects during the course of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator must provide a copy of any results communication to the sponsor for review at least 30 days prior to public release. The sponsor may request any changes necessary to prevent forfeiture of patent rights to data not in the public domain. For a multi-center study, the investigator must wait (i) at least 1 year after the study is completed at all sites or (ii) until notified by the sponsor that no multi-center publication is planned before seeking publication review.
- Publication restrictions are in place
Restriction type: OTHER