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Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

Primary Purpose

Primary Immune Deficiency

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Immune globulin subcutaneous (Human)
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Deficiency focused on measuring Immune globulin subcutaneous, SCIG, Primary immunodeficiency, PID

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who have completed the preceding follow-up study ZLB07_001CR.
  • Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject.

Exclusion Criteria:

  • Pregnancy or nursing mother.
  • Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR.
  • Subjects who are planning to donate blood during the study.
  • Known or suspected antibodies to the IMP, or to excipients of the IMP.
  • Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.

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

Annualized rate of infection episodes

Secondary Outcome Measures

Number of subjects with adverse events (AEs)
Percentage of subjects with adverse events (AEs)
Rate of AEs per infusion
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.
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
Duration of use of antibiotics for infection prophylaxis and treatment
Median serum IgG concentration

Full Information

First Posted
October 24, 2011
Last Updated
November 25, 2014
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT01461018
Brief Title
Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
Official Title
A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency
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
22 (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.
Primary Outcome Measure Information:
Title
Annualized rate of infection episodes
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events (AEs)
Time Frame
Up to 36 months
Title
Percentage of subjects with adverse events (AEs)
Time Frame
Up to 36 months
Title
Rate of AEs per infusion
Time Frame
Up to 36 months
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.
Time Frame
Up to 36 months
Title
Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections
Time Frame
Up to 36 months
Title
Number of days of hospitalization due to infections
Time Frame
Up to 36 months
Title
Duration of use of antibiotics for infection prophylaxis and treatment
Time Frame
Up to 36 months
Title
Median serum IgG concentration
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have completed the preceding follow-up study ZLB07_001CR. Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject. Exclusion Criteria: Pregnancy or nursing mother. Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR. Subjects who are planning to donate blood during the study. Known or suspected antibodies to the IMP, or to excipients of the IMP. Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yusuke Watanabe
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

Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

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