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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01199705
First received: September 8, 2010
Last updated: May 26, 2014
Last verified: March 2013
Results First Received: January 1, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Primary Immune Deficiency
Intervention: Biological: Immune Globulin Subcutaneous (Human) (SCIG)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This multicenter study enrolled subjects at nine of the participating study centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening took place 3 to 4 weeks prior to or at the first intravenous immunoglobulin (IVIG) infusion in the IVIG period of the study.

Reporting Groups
  Description
IgPro20 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.

Participant Flow for 3 periods

Period 1:   IVIG Treatment
    IgPro20  
STARTED     25  
COMPLETED     25  
NOT COMPLETED     0  

Period 2:   SCIG Treatment (Wash-in/Wash-out)
    IgPro20  
STARTED     25  
COMPLETED     24  
NOT COMPLETED     1  
Transfer of Residence                 1  

Period 3:   SCIG Treatment (Efficacy)
    IgPro20  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IgPro20 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.

Baseline Measures
    IgPro20  
Number of Participants  
[units: participants]
  25  
Age  
[units: Years]
Mean ± Standard Deviation
  20.6  ± 13.23  
Age, Customized  
[units: Participants]
 
< 2 years     0  
≥ 2 to < 12 years     7  
≥ 12 to ≤ 16 years     4  
> 16 to < 65 years     14  
≥ 65 years     0  
Gender  
[units: Participants]
 
Female     9  
Male     16  
Primary Immunodeficiency Type  
[units: Participants]
 
Common Variable Immunodeficiency (CVID)     10  
X-Linked Agammaglobulinemia (XLA)     13  
Autosomal Recessive Agammaglobulinemia (ARAG)     1  
Hyper-Immunoglobulin M (IgM) Syndrome     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   IgG Trough Level   [ Time Frame: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24 ]

2.  Secondary:   Number of Infection Episodes (Serious and Non-serious) by Study Period   [ Time Frame: Up to 36 weeks ]

3.  Secondary:   Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population   [ Time Frame: Up to 36 weeks ]

4.  Secondary:   Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population   [ Time Frame: Up to 36 weeks ]

5.  Secondary:   Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period   [ Time Frame: Up to 36 weeks ]

6.  Secondary:   Number of Days of Hospitalization Due to Infections by Study Period   [ Time Frame: Up to 36 weeks ]

7.  Secondary:   Duration of Use of Antibiotics for Infection Prophylaxis and Treatment   [ Time Frame: Up to 36 weeks ]

8.  Secondary:   Rate of All Adverse Events by Relatedness and Seriousness   [ Time Frame: For the duration of the study, up to 36 weeks ]

9.  Secondary:   Rate of Mild, Moderate, or Severe Local Reactions   [ Time Frame: For the duration of the study, up to 36 weeks ]

10.  Other Pre-specified:   Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population   [ Time Frame: Up to 36 weeks ]

11.  Other Pre-specified:   Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population   [ Time Frame: Up to 36 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
phone: Use email contact
e-mail: clinicaltrials@cslbehring.com


Publications of Results:

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01199705     History of Changes
Other Study ID Numbers: ZLB06_002CR, U1111-1116-6379
Study First Received: September 8, 2010
Results First Received: January 1, 2013
Last Updated: May 26, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency