Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01461018 |
Recruitment Status :
Completed
First Posted : October 27, 2011
Last Update Posted : December 2, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Immune Deficiency | Biological: Immune globulin subcutaneous (Human) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: IgPro20 |
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 |
- Annualized rate of infection episodes [ Time Frame: Up to 36 months ]
- Number of subjects with adverse events (AEs) [ Time Frame: Up to 36 months ]
- Percentage of subjects with adverse events (AEs) [ Time Frame: Up to 36 months ]
- Rate of AEs per infusion [ Time Frame: Up to 36 months ]
- Annualized rate of clinically documented serious bacterial infections (SBIs) [ Time Frame: Up to 36 months ]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 36 months ]
- Number of days of hospitalization due to infections [ Time Frame: Up to 36 months ]
- Duration of use of antibiotics for infection prophylaxis and treatment [ Time Frame: Up to 36 months ]
- Median serum IgG concentration [ Time Frame: Up to 36 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461018
Japan | |
Study site | |
Nagoya city, Aichi Pref., Japan, 466-8560 | |
Study site | |
Chiba city, Chiba Pref., Japan, 260-8677 | |
Study site | |
Fukuoka city, Fukuoka, Japan, 812-8582 | |
Study site | |
Gifu city, Gifu Pref., Japan, 502-8558 | |
Study Site | |
Sapporo city, Hokkaido, Japan, 060-8648 | |
Study site | |
Moriguchi city, Osaka, Japan, 570-8507 | |
Study site | |
Koshigaya city, Saitama Pref., Japan, 343-8555 | |
Study site | |
Tokorozawa city, Saitama Pref., Japan, 359-8513 | |
Study site | |
Bunkyo-ku, Tokyo Metropolitan, Japan, 113-8519 |
Study Director: | Yusuke Watanabe | CSL Behring K.K. |
Responsible Party: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT01461018 |
Other Study ID Numbers: |
IgPro20_3006 |
First Posted: | October 27, 2011 Key Record Dates |
Last Update Posted: | December 2, 2014 |
Last Verified: | November 2014 |
Immune globulin subcutaneous SCIG Primary immunodeficiency PID |
Primary Immunodeficiency Diseases Immunologic Deficiency Syndromes Immune System Diseases Genetic Diseases, Inborn Immunoglobulins Antibodies |
gamma-Globulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |