Primary Immune Deficiency Disorder

Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

NCT01458171 | PHASE 3 | INTERVENTIONAL

The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).

9 Sites

23 Participants

Recruiting

18 Years to 75 Years

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SUBMIT

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 Eligibility Criteria

Inclusion Criteria

* Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
* Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible.

Exclusion Criteria

* Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.
* Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine protein concentration \>0.2 g/L or urine protein ++ by dipstick).
* Pregnancy or nursing mother.
* Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for ZLB06_002CR.
* Subjects who are planning to donate blood during the study.
* Re-entry of subjects previously participating in the current follow-up study.
* Known or suspected antibodies to the IMP, or to excipients of the IMP.

Additional Studies

Additional studies can be found at ClinicalTrials.gov