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:
CSL Behring
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
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Immune Deficiency |
Biological: Immune globulin subcutaneous (Human) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by CSL Behring:
Primary Outcome Measures:
- Annualized rate of infection episodes [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 22 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461018
Locations
| 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 | |
Sponsors and Collaborators
CSL Behring
Investigators
| Study Director: | Yusuke Watanabe | CSL Behring K.K. |
More Information
No publications provided
| Responsible Party: | CSL Behring |
| ClinicalTrials.gov Identifier: | NCT01461018 History of Changes |
| Other Study ID Numbers: | IgPro20_3006 |
| Study First Received: | October 24, 2011 |
| Last Updated: | April 7, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by CSL Behring:
|
Immune globulin subcutaneous SCIG Primary immunodeficiency PID |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Immune System Diseases Antibodies Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013