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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

CSL Behring

ClinicalTrials.gov Identifier:

NCT01461018

First received: October 24, 2011

Last updated: April 7, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 24, 2011

Last Updated Date

April 7, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Annualized rate of infection episodes [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01461018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of subjects with adverse events (AEs) [ Time Frame: Up to 30 months ] [ Designated as safety issue: Yes ]
Percentage of subjects with adverse events (AEs) [ Time Frame: Up to 30 months ] [ Designated as safety issue: Yes ]
Rate of AEs per infusion [ Time Frame: Up to 30 months ] [ Designated as safety issue: Yes ]
Annualized rate of clinically documented serious bacterial infections (SBIs) [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
Number of days of hospitalization due to infections [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
Duration of use of antibiotics for infection prophylaxis and treatment [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
Median serum IgG concentration [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Immune Deficiency

Intervention ^ICMJE

Biological: Immune globulin subcutaneous (Human)

IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.

Other Name: Hizentra

Study Arm (s)

Experimental: IgPro20

Intervention: Biological: Immune globulin subcutaneous (Human)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

May 2014

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01461018

Other Study ID Numbers ^ICMJE

IgPro20_3006

Has Data Monitoring Committee

Not Provided

Responsible Party

CSL Behring

Study Sponsor ^ICMJE

CSL Behring

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Yusuke Watanabe

CSL Behring K.K.

Information Provided By

CSL Behring

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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