Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.

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Detailed Description

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Conditions

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Primary Immune Deficiency

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

The IgPro20 dose will be the same as in the previous pivotal study ZLB04\_009CR (NCT00419341) infused subcutaneously weekly or twice a week (in the latter case, half of a weekly dose will be used)

Group Type EXPERIMENTAL

IgPro20

Intervention Type BIOLOGICAL

Interventions

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IgPro20

Intervention Type BIOLOGICAL

Other Intervention Names

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IgG with Proline

Eligibility Criteria

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Inclusion Criteria

* Subjects with primary humoral immunodeficiency who have participated in the study ZLB04\_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID
* Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
* Written informed consent

Exclusion Criteria

* Ongoing serious bacterial infection at the time of screening
* Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
* Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration \> 0.2 g/L)
* Other significant medical conditions that could increase the risk to the patient
* Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
* A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
* Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration \> 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04\_009CR (NCT00419341)
* Creatinine concentration \> 1.5 times UNL at Completion Visit of study ZLB04\_009CR (NCT00419341)
* Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment
* Evidence of uncooperative attitude
* Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
* Subjects who are employees at the investigational site, relatives or spouse of the investigator

Minimum Eligible Age

2 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No