Primary immunodeficiency disease (PID) MedDRA version: 14.1 Level: LLT Classification code 10010509 Term: Congenital hypogammaglobulinemia System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Product Name: Intratect
Product Code: BT090
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BT090
Other descriptive name: Human normal immunoglobulin for intravenous use (IVIG)
Concen
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients (age 6–65 years) - Diagnosis of common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA) as defined by ESID/PAGID diagnostic criteria - Written informed consent - Established replacement therapy with any IVIG reference preparation during the previous 6 months, including documentation of IgG trough levels - Established replacement therapy with a single IVIG reference preparation for at least 3 months prior to treatment start with BT090, with constant IVIG dose that had not changed by ± 50% of the mean dose as well as dosage interval for at least 3 months prior to study entry and had maintained IgG trough levels of = 6g/L Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy or unreliable contraceptive measures or lactation period (women only) - Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction) - Known intolerance to proteins of human origin - Participation in another clinical trial within 90 days before entering the trial or during the trial and/or previous participation in this trial - Inability or lacking motivation to participate in the trial - Selective, absolute IgA deficiency or known antibodies to IgA - Positive diagnostics of hepatitis B and hepatitis C - Positive HIV test - Acquired medical condition known to cause secondary immune deficiency such as CLL, lymphoma, multiple myeloma - Patients with protein losing enteropathies, hypoalbuminaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of pharmacokinetics (Part A) and tolerability of BT090 at escalating infusion rates (Part B);Secondary Objective: Safety of BT090 (Part A and B);Primary end point(s): - Pharmacokinetic parameters (PART A) Analyses of the pharmacokinetic parameters will be performed for the PK analysis set. - Tolerability and safety of escalating infusion rates (PART B) Analyses of the tolerability of escalating infusion rates will be performed for the safety set. ;Timepoint(s) of evaluation of this end point: Part A: about 3 months/first 3 infusions, PK at 3rd infusion Part B: about 6 months/4th - 6th infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety - number of AEs temporally associated with the infusion (occurring during infusion or within 72 hours after end of infusion) - number of all other adverse events including safety laboratory parameters - vital signs (change from initial/pre-infusion values) > body temperature > blood pressure > pulse rate;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Germany, Hungary
Contacts
Public ContactClinical Trial Information
Biotest AG
Outcome results
None listed