Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-10-31

Brief Summary

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The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.

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Detailed Description

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Conditions

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Common Variable Immunodeficiency Agammaglobulinemia

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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Vivaglobin

Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.

Group Type EXPERIMENTAL

Vivaglobin

Intervention Type DRUG

Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.

Interventions

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Vivaglobin

Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent, age-adapted
* Male or female aged 1 to 70 years
* Diagnosis of primary humoral immunodeficiency
* No prior immunoglobulin substitution therapy
* IgG level of \<5 g/L at screening
* Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening

Exclusion Criteria

* Evidence of serious infection between screening and first treatment
* Bleeding disorders that require medical treatments
* Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
* Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No