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Follow-up 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:
NCT01458171
First received: October 12, 2011
Last updated: February 27, 2013
Last verified: February 2013
Results First Received: February 27, 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 Disorder
Intervention: Biological: Immune globulin subcutaneous (Human)

  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 study centers in Japan who had participated in the preceding pivotal study ZLB06_002CR (CT.gov identifier: NCT01199705).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only subjects participating in the preceding pivotal study ZLB06_002CR (NCT01199705) were eligible. The enrolment visit of this study was on the same day as the completion visit of the preceding pivotal study ZLB06_002CR.

Reporting Groups
  Description
IgPro20 Immune globulin subcutaneous (Human): 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).

Participant Flow:   Overall Study
    IgPro20  
STARTED     23  
COMPLETED     22  
NOT COMPLETED     1  
Adverse Event                 1  



  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 (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).

Baseline Measures
    IgPro20  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Mean ± Standard Deviation
  20.8  ± 13.68  
Gender  
[units: participants]
 
Female     9  
Male     14  



  Outcome Measures
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1.  Primary:   Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion   [ Time Frame: 24 weeks ]

2.  Secondary:   Overall Rate of AEs Per Infusion   [ Time Frame: 24 weeks ]

3.  Secondary:   Number of Subjects With Newly Developing or Worsening AEs   [ Time Frame: 24 weeks ]

4.  Secondary:   Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'   [ Time Frame: 24 to 72 hours after infusion ]

5.  Secondary:   IgG Trough Level   [ Time Frame: 24 weeks ]

6.  Secondary:   Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)   [ Time Frame: 24 weeks ]

7.  Secondary:   Number of Infection Episodes (Serious and Non-serious)   [ Time Frame: 24 weeks ]

8.  Secondary:   Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.   [ Time Frame: 24 weeks ]

9.  Secondary:   Number of Days of Hospitalization Due to Infections.   [ Time Frame: 24 weeks ]

10.  Secondary:   Duration of Use of Antibiotics for Infection Prophylaxis and Treatment   [ Time Frame: 24 weeks ]

11.  Other Pre-specified:   Rate of Infection Episodes (Serious and Non-serious)   [ Time Frame: 24 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


No publications provided


Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01458171     History of Changes
Other Study ID Numbers: ZLB07_001CR
Study First Received: October 12, 2011
Results First Received: February 27, 2013
Last Updated: February 27, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency