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

March 5, 2014 updated by: CSL Behring

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)

This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75743
        • Study Site
  • Germany
      • Berlin, Germany, 13353
        • Study Site
      • Freiburg, Germany, 79095
        • Study Site
      • Leipzig, Germany, 04129
        • Study Site
      • Mainz, Germany, 55131
        • Study Site
  • Poland
      • Warsaw, Poland
        • Study Site
  • Romania
      • Cluj-Napoca, Romania, 400162
        • Study Site
      • Timisoara, Romania, 300011
        • Study Site
  • Spain
      • Barcelona, Spain, 08036
        • Study Site
      • Sevilla, Spain, 41013
        • Study Site
  • Sweden
      • Göteborg, Sweden, 41685
        • Study Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Study Site
  • United Kingdom
      • London, United Kingdom, EC1A7BE
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 IgPro well
  • Written informed consent

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IgPro20
Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
Biological: IgPro20
Other Names:
  • Hizentra
  • IgG with Proline (IgPro)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Serum IgG Trough Levels
Time Frame: Up to 42 months
The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.
Up to 42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)
Time Frame: Up to 42 months

The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.

Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs.
Up to 42 months
Annualized Rate of Infection Episodes
Time Frame: Up to 42 months
The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Up to 42 months
Number of Infection Episodes
Time Frame: Up to 42 months
Total number of infections for the specified analysis population
Up to 42 months
Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
Time Frame: Up to 42 months
The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.
Up to 42 months
Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections
Time Frame: Up to 42 months
Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population
Up to 42 months
Annualized Rate of Hospitalization Due to Infections
Time Frame: Up to 42 months
The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.
Up to 42 months
Number of Days of Hospitalization Due to Infections
Time Frame: Up to 42 months
Total number of days of hospitalization due to infections for the specified analysis population
Up to 42 months
Use of Antibiotics for Infection Prophylaxis and Treatment
Time Frame: Up to 42 months
Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.
Up to 42 months
Health Related Quality of Life (Short Form 36 Health Survey)
Time Frame: At baseline and at the last available post-baseline observation for each subject (up to 42 months)
The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.
At baseline and at the last available post-baseline observation for each subject (up to 42 months)
Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.
Time Frame: At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).
The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).
Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.
Time Frame: At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).
The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis.
At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).
Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion
Time Frame: Up to 42 months
The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Up to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZLB07_002CR
  • 1472 (Other Identifier: CSL Behring)
  • 2008-000830-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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