Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID

Phase 3

Completed

Brief Summary: This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
BT595	IgG Next Generation (BT595)	Subjects received BT595 (100 mg/mL human normal immunoglobulin) at doses between 0.2 and 0.8 g per kg body weight (bw) (2 to 8 mL/kg bw), either at a Q3W or Q4W schedule, The initial doses and dosage interval had to be consistent with the subject's prestudy IVIg treatment.

Primary Outcome Measures

Name	Time	Method
Rate of Acute Serious Bacterial Infections	approx. 12 month treatment period	The primary efficacy endpoint was the rate of acute serious bacterial infections, ie, the mean number of acute serious bacterial infections \[SBIs as defined by EMA and FDA\] per subject-year.

Secondary Outcome Measures

Name	Time	Method
IgG Trough Levels (Total IgG) Before Each Infusion	approx. 12 month treatment period	Total IgG levels \[g/L\] before each infusion, mean (SD)
Rate of Any Infections	approx. 12 month treatment period	The annual rate of infections was calculated as the number of all infections (serious plus nonserious) per subject-year
Time to Resolution of Infections	approx. 12 month treatment period	Time to resolution of infections (days) was calculated as infection stop date - infection start date +1.
Rate of Nonserious Infections	approx. 12 month treatment period	The annual rate of nonserious infections was calculated as the number of nonserious infections per subject-year
Rate of Time Lost From School/Work Due to Infections	approx. 12 month treatment period	Annual rates of the number of days subjects are not able to attend school/work due to infections and their treatment will be calculated per subject-year.
Antibiotic Treatment Information	approx. 12 month treatment period	Median (min-max) number of days on antibiotics treatment per subject
Hospitalization / Hospitalization Due to Infection	approx. 12 month treatment period	Annual rates of the number of days of hospitalization (any hospitalization/ hospitalization due to infection) will be calculated per subject-year.
Fever Episodes	approx. 12 month treatment period	The number of days with episodes of fever will be calculated as the number of fever episodes per subject-year. Fever is defined as a body temperature ≥38°C (≥100.4°F).

Locations (19): Investigational site # 4904
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Freiburg, Germany
Investigational site # 0106
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South Bend, Indiana, United States
Investigational site # 0114
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Thornton, Colorado, United States
Investigational site # 0105
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Toledo, Ohio, United States
Investigational site # 0104
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Birmingham, Alabama, United States
Investigational site # 0103
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Centennial, Colorado, United States
Investigational site # 0111
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Chicago, Illinois, United States
Investigational site #3603
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Nyíregyháza, Hungary
Investigational site # 3602
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Budapest, Hungary
Investigational site # 0702
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Moscow, Russian Federation
Investigational site # 0116
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Los Angeles, California, United States
Investigational Site # 0102
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Dallas, Texas, United States
Investigational site # 4902
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Frankfurt am Main, Germany
Investigational site #4905
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Leipzig, Germany
Investigational Site # 3605
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Miskolc, Hungary
Investigational site # 3405
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Madrid, Spain
Investigational site # 3403
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Barcelona, Spain
Investigational site # 0704
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Yekaterinburg, Russian Federation
Investigational site #0115
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Memphis, Tennessee, United States