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

NCT01461018 | Completed Phase 3

• 1 other identifier: IgPro20_3006
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 9

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).

Conditions

Primary Immune Deficiency

Keywords

Immune globulin subcutaneous; SCIG; Primary immunodeficiency; PID

Outcome Measures

Primary Outcomes (1)

• Annualized rate of infection episodes

  Up to 36 months

Secondary Outcomes (8)

• Number of subjects with adverse events (AEs)

  Up to 36 months

• Percentage of subjects with adverse events (AEs)

  Up to 36 months

• Rate of AEs per infusion

  Up to 36 months

• Annualized rate of clinically documented serious bacterial infections (SBIs)

  Up to 36 months

• Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections

  Up to 36 months

Study Arms (1)

IgPro20

EXPERIMENTAL

Biological: Immune globulin subcutaneous (Human)

Interventions

Immune globulin subcutaneous (Human) BIOLOGICAL

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

Also known as: Hizentra

IgPro20

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (9)

Study site

Nagoya, Aichi Pref., 466-8560, Japan

Location

Study site

Chiba, Chiba Pref., 260-8677, Japan

Location

Study site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Study site

Gifu, Gifu Pref., 502-8558, Japan

Location

Study Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Study site

Moriguchi, Osaka, 570-8507, Japan

Location

Study site

Koshigaya, Saitama Pref., 343-8555, Japan

Location

Study site

Tokorozawa, Saitama Pref., 359-8513, Japan

Location

Study site

Bunkyō City, Tokyo Metropolitan, 113-8519, Japan

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

gamma-Globulins; Hizentra

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yusuke Watanabe

  CSL Behring K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 27, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

JP (9)