A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency (IgPro20 EU Extension Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000830-30-DE

Enrollment

Registered

2008-06-09

Start date

2008-07-10

Completion date

Unknown

Last updated

2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PID (primary immuno deficiency) MedDRA version: 9.1 Level: LLT Classification code 10064859 Term: Primary immunodeficiency syndrome

Interventions

Product Name: IgPro20 Product Code: IgPro20 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Normal Immunoglobulin Concentration unit: % percent Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common variable immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and the European Society for Immunodeficiencies (ESID) or X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID or autosomal recessive agammaglobulinemia who have participated in the study ZLB06_001CR and who have tolerated IgPro20 well • Written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total urine protein concentration > 0.2g/L) • Other significant medical conditions that could increase the risk to the subject • Females who are pregnant, breast feeding or planning a pregnancy during the course of the study • Participation in a study with an investigational medicinal product within three months prior to enrollment, except for ZLB06_001CR • Evidence of uncooperative attitude • Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study • Subjects who are employees at the investigational site, relatives or spouse of the investigator

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with PID. ;Secondary Objective: The objective of the HRQL assessment is to evaluate the maintenance of HRQL while the subject is on long-term SCIG treatment during the extension study.;Primary end point(s): The efficacy endpoints in this study include the descriptive comparison of serum IgG levels at visit 1, 3, 5, 7, 9, 11, 13 and 15. Evaluation of safety includes the analysis of AEs and the analysis of laboratory examinations. The severity and relatedness to the IMP of AEs will be observed.	—

Measure

Time frame

Main Objective: The objective of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with PID. ;Secondary Objective: The objective of the HRQL assessment is to evaluate the maintenance of HRQL while the subject is on long-term SCIG treatment during the extension study.;Primary end point(s): The efficacy endpoints in this study include the descriptive comparison of serum IgG levels at visit 1, 3, 5, 7, 9, 11, 13 and 15. Evaluation of safety includes the analysis of AEs and the analysis of laboratory examinations. The severity and relatedness to the IMP of AEs will be observed.

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Countries

France, Germany, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026