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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 75
Updated:4/6/2019
Start Date:October 2016
End Date:April 2020
Contact:Frauke Schulz
Email:frauke_schulz@biotest.de
Phone:+49 6103 801

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An Open-label, Prospective, Multicenter Study Investigating Clinical Efficacy, Safety, and Pharmacokinetic Properties of the Human Normal Immunoglobulin for Intravenous Administration BT595 as Replacement Therapy in Patients With Primary Immunodeficiency Disease (PID)

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


Main Inclusion Criteria:

- Written informed consent/assent obtained from subjects/subjects' parent(s) or legally
acceptable representative indicating that they understand the purpose of and
procedures required for the study and are willing to participate in it.

- Male or female, aged 2 through 75 years.

- Diagnosis of PID with impaired antibody production, i.e.:

Diagnosis of common variable immunodeficiency (CVID) as defined by the European Society for
Immunodeficiencies (ESID)/Pan American Group for Immunodeficiency (PAGID) diagnostic
criteria.

Or

- X linked agammaglobulinemia (XLA) as defined by ESID/PAGID diagnostic criteria.

- Established replacement therapy with any intravenous immunoglobulin (IVIg) reference
preparation during the previous 6 months, including documentation of immunoglobulin G
(IgG) trough levels.

- Established replacement therapy with a single IVIg reference preparation for at least
3 months prior to treatment start with BT595 at a 3 or 4 week schedule with a constant
IVIg dose that did not change by ±20% of the mean dose, regular dosage intervals, and
at least 1 IgG trough level of ≥5 g/L during the previous 3 months.

Main Exclusion Criteria:

- Known intolerance to immunoglobulins or comparable substances (e.g., vaccination
reaction).

- Known intolerance to proteins of human origin or known allergic reactions to
components of the study product.

- Acquired medical conditions known to cause secondary immune deficiency, such as
chronic lymphatic leukemia, lymphoma, multiple myeloma, as well as protein losing
enteropathies and hypoalbuminemia.

- Recent febrile illness that precludes or delays participation.

- Active infection and receiving antibiotic therapy for the treatment of this infection
at the time of screening. Note: if the subject is deemed to be a screen failure due to
a nonserious active infection requiring antibiotic therapy, the subject may be
rescreened after the initial screening.

- Therapy with systemic steroids or other immunosuppressant drugs at the time of
enrollment (current daily use of corticosteroids, i.e., >10 mg prednisone
equivalent/day for >30 days. Intermittent corticosteroid use during the study is
allowable, if medically necessary).

- History of thrombotic events (including myocardial infarction, cerebral vascular
accident [including stroke], pulmonary embolism, and deep vein thrombosis) within the
6 months before treatment start with BT595 or the presence of significant risk factors
for thrombotic events.

- Therapy with live attenuated virus vaccines within 3 months before start of the study.

- Selective, absolute immunoglobulin A (IgA) deficiency or known antibodies to IgA.
We found this trial at
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