Primary Immune Deficiency

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

NCT01199705 | PHASE 3 | INTERVENTIONAL

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

10 Sites

25 Participants

Recruiting

15 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

Gifu city,Gifu Pref.,Japan,501-1194

Study site

Sapporo city,Hokkaido,Japan,060-8648

Study site

Sendai city,Miyagi Pref.,Japan,980-8574

Study site

Fukuoka city,Osaka,Japan,812-8582

Study site

Moriguchi city,Osaka,Japan,570-8507

Study site

Osaka city,Osaka,Japan,534-0021

Study site

Koshigaya city,Saitama Pref.,Japan,343-8555

Study site

Tokorozawa city,Saitama Pref.,Japan,359-8513

Study Eligibility Criteria

Inclusion Criteria

* Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
* Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
* Written informed consent

Exclusion Criteria

* Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
* Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
* Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
* Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
* Pregnancy or nursing mother
* A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
* Participation in a study with other investigational product during this study and within 3 months prior to screening
* Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study

Additional Studies

Additional studies can be found at ClinicalTrials.gov