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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Primary Immune Deficiency Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IgPro20

Group Type EXPERIMENTAL

Immune globulin subcutaneous (Human)

Intervention Type BIOLOGICAL

IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).

Interventions

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Immune globulin subcutaneous (Human)

IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).

Intervention Type BIOLOGICAL

Other Intervention Names

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Hizentra

Eligibility Criteria

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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.

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No