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

Phase 3CompletedNCT01199705

CSL Behring25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Immune Deficiency

Interventions

Immune Globulin Subcutaneous (Human) (SCIG)BIOLOGICAL

IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (10)

Study site

Nagoya, Aichi Pref., Japan

Study site

Chiba, Chiba Pref., Japan

Study site

Gifu, Gifu Pref., Japan

Study site

Sapporo, Hokkaido, Japan

Outcomes

Primary Outcomes

IgG Trough Level

Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.

Time frame: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24

Secondary Outcomes

Number of Infection Episodes (Serious and Non-serious) by Study Period

Number of infection episodes (serious and non-serious) presented by study period: * IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20). * SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. * SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.

Time frame: Up to 36 weeks

Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population

The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks) * SCIG IgPro20 treatment (efficacy) (12 weeks)

Time frame: Up to 36 weeks

Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population

Data from ClinicalTrials.gov

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