Back to resultsFollow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Primary Purpose
Primary Immune Deficiency Disorder
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Immune globulin subcutaneous (Human)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immune Deficiency Disorder focused on measuring Immune globulin subcutaneous, SCIG, Primary immunodeficiency, PID
Eligibility Criteria
Inclusion Criteria:
- Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
- Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.
Exclusion Criteria:
- Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration >0.2 g/L or urine protein ++ by dipstick).
- Pregnancy or nursing mother.
- Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06_002CR.
- Subjects who are planning to donate blood during the study.
- Re-entry of subjects previously participating in the current follow-up study.
- Known or suspected antibodies to the IMP, or to excipients of the IMP.
Sites / Locations
- Study site
- Study site
- Study site
- Study site
- Study site
- Study site
- Study site
- Study site
- Study site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IgPro20
Arm Description
Outcomes
Primary Outcome Measures
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion
The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).
Secondary Outcome Measures
Overall Rate of AEs Per Infusion
The rate was calculated by counting all newly developed or worsened AEs during the treatment period in all subjects and dividing the total number of AEs by the total number of IgPro20 infusions administered. In addition, individual AEs were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]). The AE rates per infusion by severity and causal relationship to study medication were calculated by dividing the number of AEs in each category by the total number of IgPro20 infusions.
Number of Subjects With Newly Developing or Worsening AEs
Number of subjects with AEs, overall and classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).
Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'
Subjects assessed their overall perception of local tolerability at the infusion site throughout the study in the subject diary within a time window of 24 h to 72 h after the end of the latest infusion by assessing it as "very good", "good", "fair", or "poor". The reported percentage represents the percentage of subjects with local tolerability assessments of "very good" or "good" at any given study infusion.
IgG Trough Level
Serum IgG trough levels at the completion visit compared to the baseline visit of the follow-up study. IgG trough levels at baseline, at the completion visit, and the change from baseline to the completion visit are shown
Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the FAS and PPS and adjusted to 365 days.
Number of Infection Episodes (Serious and Non-serious)
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.
Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections.
Number of Days of Hospitalization Due to Infections.
Median number of days of hospitalization due to infections.
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
Median number of days of use of antibiotics for infection prophylaxis and/or treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01458171
Brief Title
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Official Title
A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency Disorder
Keywords
Immune globulin subcutaneous, SCIG, Primary immunodeficiency, PID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IgPro20
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Immune globulin subcutaneous (Human)
Other Intervention Name(s)
Hizentra
Intervention Description
IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
Primary Outcome Measure Information:
Title
Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion
Description
The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Overall Rate of AEs Per Infusion
Description
The rate was calculated by counting all newly developed or worsened AEs during the treatment period in all subjects and dividing the total number of AEs by the total number of IgPro20 infusions administered. In addition, individual AEs were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]). The AE rates per infusion by severity and causal relationship to study medication were calculated by dividing the number of AEs in each category by the total number of IgPro20 infusions.
Time Frame
24 weeks
Title
Number of Subjects With Newly Developing or Worsening AEs
Description
Number of subjects with AEs, overall and classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).
Time Frame
24 weeks
Title
Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'
Description
Subjects assessed their overall perception of local tolerability at the infusion site throughout the study in the subject diary within a time window of 24 h to 72 h after the end of the latest infusion by assessing it as "very good", "good", "fair", or "poor". The reported percentage represents the percentage of subjects with local tolerability assessments of "very good" or "good" at any given study infusion.
Time Frame
24 to 72 hours after infusion
Title
IgG Trough Level
Description
Serum IgG trough levels at the completion visit compared to the baseline visit of the follow-up study. IgG trough levels at baseline, at the completion visit, and the change from baseline to the completion visit are shown
Time Frame
24 weeks
Title
Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
Description
SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the FAS and PPS and adjusted to 365 days.
Time Frame
24 weeks
Title
Number of Infection Episodes (Serious and Non-serious)
Time Frame
24 weeks
Title
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.
Description
Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections.
Time Frame
24 weeks
Title
Number of Days of Hospitalization Due to Infections.
Description
Median number of days of hospitalization due to infections.
Time Frame
24 weeks
Title
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
Description
Median number of days of use of antibiotics for infection prophylaxis and/or treatment
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Rate of Infection Episodes (Serious and Non-serious)
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 FAS population and the PPS population and adjusted to 365 days.
Time Frame
24 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.
Exclusion Criteria:
Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration >0.2 g/L or urine protein ++ by dipstick).
Pregnancy or nursing mother.
Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06_002CR.
Subjects who are planning to donate blood during the study.
Re-entry of subjects previously participating in the current follow-up study.
Known or suspected antibodies to the IMP, or to excipients of the IMP.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Midori Kobayashi
Organizational Affiliation
CSL Behring K.K.
Official's Role
Study Director
Facility Information:
Facility Name
Study site
City
Nagoya city
State/Province
Aichi Pref.
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Study site
City
Chiba city
State/Province
Chiba Pref.
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Study site
City
Fukuoka city
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Study site
City
Gifu city
State/Province
Gifu Pref.
ZIP/Postal Code
502-8558
Country
Japan
Facility Name
Study site
City
Sapporo city
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Study site
City
Moriguchi city
State/Province
Osaka
ZIP/Postal Code
570-8507
Country
Japan
Facility Name
Study site
City
Koshigaya city
State/Province
Saitama Pref.
ZIP/Postal Code
343-8555
Country
Japan
Facility Name
Study site
City
Tokorozawa city
State/Province
Saitama Pref.
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Study site
City
Bunkyo-ku
State/Province
Tokyo Metropolitan
ZIP/Postal Code
113-8519
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
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