ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01199705
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : March 20, 2013
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Immune Deficiency
Intervention Biological: Immune Globulin Subcutaneous (Human) (SCIG)
Enrollment 25

Recruitment Details This multicenter study enrolled subjects at nine of the participating study centers in Japan.
Pre-assignment Details Screening took place 3 to 4 weeks prior to or at the first intravenous immunoglobulin (IVIG) infusion in the IVIG period of the study.
Arm/Group Title IgPro20
Hide Arm/Group Description Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
Period Title: IVIG Treatment
Started 25
Completed 25
Not Completed 0
Period Title: SCIG Treatment (Wash-in/Wash-out)
Started 25
Completed 24
Not Completed 1
Reason Not Completed
Transfer of Residence             1
Period Title: SCIG Treatment (Efficacy)
Started 24
Completed 24
Not Completed 0
Arm/Group Title IgPro20
Hide Arm/Group Description Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
20.6  (13.23)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
< 2 years 0
≥ 2 to < 12 years 7
≥ 12 to ≤ 16 years 4
> 16 to < 65 years 14
≥ 65 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
9
  36.0%
Male
16
  64.0%
Primary Immunodeficiency Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
Common Variable Immunodeficiency (CVID) 10
X-Linked Agammaglobulinemia (XLA) 13
Autosomal Recessive Agammaglobulinemia (ARAG) 1
Hyper-Immunoglobulin M (IgM) Syndrome 1
1.Primary Outcome
Title IgG Trough Level
Hide Description Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.
Time Frame During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability. The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
Arm/Group Title IgPro20 - Per Protocol Set (PPS) IgPro20 - Full Analysis Set (FAS)
Hide Arm/Group Description:
The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
Overall Number of Participants Analyzed 21 24
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Ratio of Geometric Means
1.09
(1.06 to 1.13)
1.11
(1.08 to 1.15)
2.Secondary Outcome
Title Number of Infection Episodes (Serious and Non-serious) by Study Period
Hide Description

Number of infection episodes (serious and non-serious) presented by study period:

  • IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
  • SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
  • SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
Time Frame Up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IgPro20 - Per Protocol Set (PPS) IgPro20 - Full Analysis Set (FAS)
Hide Arm/Group Description:
The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
Overall Number of Participants Analyzed 21 24
Measure Type: Number
Unit of Measure: Number of infection episodes
IVIG Treatment 19 22
SCIG IgPro20 Treatment (Wash-in/Wash-out) 28 32
SCIG IgPro20 Treatment (Efficacy) 15 18
3.Secondary Outcome
Title Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population
Hide Description

The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.

Study periods:

  • IVIG treatment (up to 12 weeks)
  • SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)
  • SCIG IgPro20 treatment (efficacy) (12 weeks)
Time Frame Up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
Arm/Group Title IVIG Treatment SCIG Treatment (Wash-in/Wash-out) SCIG Treatment (Efficacy)
Hide Arm/Group Description:
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
Overall Number of Participants Analyzed 21 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Subject Study Days
1209 1764 1840
Measure Type: Number
Unit of Measure: Infections per subject year
5.74 5.79 2.98
4.Secondary Outcome
Title Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population
Hide Description

The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.

Study periods:

  • IVIG treatment (up to 12 weeks)
  • SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)
  • SCIG IgPro20 treatment (efficacy) (12 weeks)
Time Frame Up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
Arm/Group Title IVIG Treatment SCIG Treatment (Wash-in/Wash-out) SCIG Treatment (Efficacy)
Hide Arm/Group Description:
Subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
Overall Number of Participants Analyzed 24 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Subject Study Days
1396 2016 2095
Measure Type: Number
Unit of Measure: Infections per subject year
5.75 5.79 3.14
5.Secondary Outcome
Title Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period
Hide Description Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Time Frame Up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IgPro20 - Per Protocol Set (PPS) IgPro20 - Full Analysis Set (FAS)
Hide Arm/Group Description:
The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
Overall Number of Participants Analyzed 21 24
Median (Full Range)
Unit of Measure: Days
IVIG Treatment
0
(0 to 8)
0
(0 to 8)
SCIG IgPro20 Treatment (Wash-in/Wash-out)
0
(0 to 9)
0
(0 to 9)
SCIG IgPro20 Treatment (Efficacy)
0
(0 to 8)
0
(0 to 8)
6.Secondary Outcome
Title Number of Days of Hospitalization Due to Infections by Study Period
Hide Description Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Time Frame Up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IgPro20 - Per Protocol Set (PPS) IgPro20 - Full Analysis Set (FAS)
Hide Arm/Group Description:
The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
Overall Number of Participants Analyzed 21 24
Median (Full Range)
Unit of Measure: Days
IVIG Treatment
0
(0 to 1)
0
(0 to 1)
SCIG IgPro20 Treatment (Wash-in/Wash-out)
0
(0 to 0)
0
(0 to 0)
SCIG IgPro20 Treatment (Efficacy)
0
(0 to 3)
0
(0 to 3)
7.Secondary Outcome
Title Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
Hide Description Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Time Frame Up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IgPro20 - Per Protocol Set (PPS) IgPro20 - Full Analysis Set (FAS)
Hide Arm/Group Description:
The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
Overall Number of Participants Analyzed 21 24
Median (Full Range)
Unit of Measure: Days
IVIG Treatment
48.5
(2 to 64)
48.0
(2 to 64)
SCIG IgPro20 Treatment (Wash-in/Wash-out)
49.0
(3 to 86)
35.5
(2 to 86)
SCIG IgPro20 Treatment (Efficacy)
71.0
(6 to 85)
71.0
(6 to 85)
8.Secondary Outcome
Title Rate of All Adverse Events by Relatedness and Seriousness
Hide Description The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Time Frame For the duration of the study, up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety data set (SDS) comprised all subjects treated with the study drug.
Arm/Group Title IVIG Treatment SCIG Treatment
Hide Arm/Group Description:
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
Overall Number of Participants Analyzed 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
75 584
Measure Type: Number
Unit of Measure: AEs per infusion
All AEs 0.653 0.457
At Least Possibly Related AEs 0.027 0.296
Serious AEs 0 0.002
At Least Possibly Related and Serious AEs 0 0
9.Secondary Outcome
Title Rate of Mild, Moderate, or Severe Local Reactions
Hide Description

In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.

Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity.

Time Frame For the duration of the study, up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug.
Arm/Group Title IVIG Treatment SCIG Treatment
Hide Arm/Group Description:
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
Overall Number of Participants Analyzed 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
75 584
Measure Type: Number
Unit of Measure: AEs per infusion
Mild Local Reactions 0 0.274
Moderate Local Reactions 0 0
Severe Local Reactions 0 0
10.Other Pre-specified Outcome
Title Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population
Hide Description

The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.

Study periods:

  • IVIG treatment (up to 12 weeks)
  • SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)
  • SCIG IgPro20 treatment (efficacy; 12 weeks)
Time Frame Up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
Arm/Group Title IVIG Treatment SCIG IgPro20 Treatment (Wash-in/Wash-out) SCIG IgPro20 Treatment (Efficacy)
Hide Arm/Group Description:
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
Weekly SC IgPro20 infusions for a 12-week efficacy period.
Overall Number of Participants Analyzed 21 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Subject Study Days
1209 1764 1840
Measure Type: Number
Unit of Measure: SBIs per subject year
0.00 0.00 0.00
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IVIG Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Annualized Rate
Estimated Value 0.00
Confidence Interval (1-Sided) 99%
1.390
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SCIG IgPro20 Treatment (Wash-in/Wash-out)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Annualized Rate
Estimated Value 0.00
Confidence Interval (1-Sided) 99%
0.953
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SCIG IgPro20 Treatment (Efficacy)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Annualized Rate
Estimated Value 0.00
Confidence Interval (1-Sided) 99%
0.914
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population
Hide Description

The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.

Study periods:

  • IVIG treatment (up to 12 weeks)
  • SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)
  • SCIG IgPro20 treatment (efficacy; 12 weeks)
Time Frame Up to 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
Arm/Group Title IVIG Treatment SCIG IgPro20 Treatment (Wash-in/Wash-out) SCIG IgPro20 Treatment (Efficacy)
Hide Arm/Group Description:
Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
Weekly SC IgPro20 infusions for a 12-week efficacy period.
Overall Number of Participants Analyzed 24 24 24
Overall Number of Units Analyzed
Type of Units Analyzed: Subject Study Days
1396 2016 2095
Measure Type: Number
Unit of Measure: SBIs per subject year
0.00 0.00 0.00
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IVIG Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Annualized Rate
Estimated Value 0.00
Confidence Interval (1-Sided) 99%
1.204
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SCIG IgPro20 Treatment (Wash-in/Wash-out)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Annualized Rate
Estimated Value 0.00
Confidence Interval (1-Sided) 99%
0.834
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SCIG IgPro20 Treatment (Efficacy)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Annualized Rate
Estimated Value 0.00
Confidence Interval (1-Sided) 99%
0.802
Estimation Comments [Not Specified]
Time Frame For the duration of the study, up to 36 weeks
Adverse Event Reporting Description The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.
 
Arm/Group Title IVIG Treatment SCIG Treatment
Hide Arm/Group Description Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20). IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
All-Cause Mortality
IVIG Treatment SCIG Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IVIG Treatment SCIG Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      1/25 (4.00%)    
Infections and infestations     
Bacterial infection  1  0/25 (0.00%)  0 1/25 (4.00%)  1
Gastroenteritis  1 [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
[1]
This SAE occurred between screening and the first IVIG dose and was thus non-treatment-emergent.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IVIG Treatment SCIG Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/25 (80.00%)      24/25 (96.00%)    
Gastrointestinal disorders     
Dental caries  1  1/25 (4.00%)  1 3/25 (12.00%)  3
Vomiting  1  2/25 (8.00%)  2 0/25 (0.00%)  0
General disorders     
Local reactions  [1]  0/25 (0.00%)  0 20/25 (80.00%)  160
Malaise  1  2/25 (8.00%)  2 1/25 (4.00%)  2
Infections and infestations     
Bronchitis  1  0/25 (0.00%)  0 3/25 (12.00%)  3
Conjunctivitis infective  1  1/25 (4.00%)  1 2/25 (8.00%)  2
Gastroenteritis  1  1/25 (4.00%)  1 3/25 (12.00%)  5
Influenza  1  4/25 (16.00%)  4 4/25 (16.00%)  4
Nasopharyngitis  1  5/25 (20.00%)  8 11/25 (44.00%)  21
Sinusitis  1  0/25 (0.00%)  0 3/25 (12.00%)  3
Upper respiratory tract infection  1  4/25 (16.00%)  4 5/25 (20.00%)  8
Pharyngitis  1  3/25 (12.00%)  3 1/25 (4.00%)  1
Injury, poisoning and procedural complications     
Arthropod bite  1  0/25 (0.00%)  0 3/25 (12.00%)  7
Contusion  1  2/25 (8.00%)  2 2/25 (8.00%)  2
Nervous system disorders     
Headache  1  3/25 (12.00%)  3 1/25 (4.00%)  1
Skin and subcutaneous tissue disorders     
Rash  1  0/25 (0.00%)  0 3/25 (12.00%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
[1]
Local reactions cover MedDRA PTs: infusion site: discomfort, erythema, haemorrhage, induration, inflammation, pain, pruritus, swelling; injection site: erythema, extravasation, induration, irritation, pain, pruritus, swelling; puncture site reaction.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
Phone: Use email contact
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01199705     History of Changes
Other Study ID Numbers: ZLB06_002CR
U1111-1116-6379 ( Other Identifier: WHO Universal Trial Number )
First Submitted: September 8, 2010
First Posted: September 13, 2010
Results First Submitted: January 1, 2013
Results First Posted: March 20, 2013
Last Update Posted: December 12, 2014