PID (Primary Immunodeficiency) MedDRA version: 9.1 Level: LLT Classification code 10064859 Term: Primary immunodeficiency syndrome
Conditions
Interventions
Product Name: IgPro20
Product Code: IgPro20
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human Immunglobulin G (IgG)
Concentration unit: % percent
Concentration type: equal
Concentr
Sponsors
CSL Behring AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Male or female aged > 24 months and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin replacement therapy · 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 · Known hyperprolinemia · Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L) · Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA · The subject is receiving steroids (oral and parenteral, daily = 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants · 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: HIV, HCV or HBV · ASAT or ALAT concentration > 2.5 times ULNR · Creatinine concentration > 1.5 times ULNR · Participation in a study with an investigational product other than immunoglobulin 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 · Patients who are employees at the investigational site, relatives or spouse of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary variable of this study is to descriptively compare IgG trough levels at 6 consecutive weeks at steady state within the study, i.e. IgG levels prior to infusions 12 to 17, with 3 trough levels obtained from the subject’s previous treatment during the last 3 to 6 months prior to the study.;Main Objective: The primary objective of this study is to achieve sustained total serum IgG trough levels comparable to the previous IgG treatment in the ITT population. This will be evaluated from a descriptive comparison of three trough levels measured during previous treatment prior to the study with six consecutive trough levels measured at a steady state period within the study.;Secondary Objective: Secondary efficacy objectives of the study are the rate of clinically documented serious bacterial infections, the number of infection episodes, the number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, the number of days of hospitalization due to infections, and the use of antibiotics for infection prophylaxis and treatment. Safety objectives of this study are monitoring of short-term tolerance (blood pressure, heart rate, body temperature), the local tolerability of subcutaneous infusions, monitoring of adverse events, vital sign changes before and after infusions at the study site, and changes in routine laboratory parameters as compared to baseline assessments. | — |
Countries
France, Germany, Italy, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed