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

Primary Immune Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461018
• Other study ID #: IgPro20_3006
• Status: Completed
• Phase: Phase 3
• First received: October 24, 2011
• Last updated: November 25, 2014
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency

Intervention

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

Locations

Country	Name	City	State
Japan	Study site	Bunkyo-ku	Tokyo Metropolitan
Japan	Study site	Chiba city	Chiba Pref.
Japan	Study site	Fukuoka city	Fukuoka
Japan	Study site	Gifu city	Gifu Pref.
Japan	Study site	Koshigaya city	Saitama Pref.
Japan	Study site	Moriguchi city	Osaka
Japan	Study site	Nagoya city	Aichi Pref.
Japan	Study Site	Sapporo city	Hokkaido
Japan	Study site	Tokorozawa city	Saitama Pref.

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized rate of infection episodes		Up to 36 months	No
Secondary	Number of subjects with adverse events (AEs)		Up to 36 months	Yes
Secondary	Percentage of subjects with adverse events (AEs)		Up to 36 months	Yes
Secondary	Rate of AEs per infusion		Up to 36 months	Yes
Secondary	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.	Up to 36 months	No
Secondary	Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections		Up to 36 months	No
Secondary	Number of days of hospitalization due to infections		Up to 36 months	No
Secondary	Duration of use of antibiotics for infection prophylaxis and treatment		Up to 36 months	No
Secondary	Median serum IgG concentration		Up to 36 months	No