Eine offene, prospektive Studie zur Untersuchung der Pharmakokinetikund Sicherheit (Teil A) des Immunglobulins vom Menschen zurintravenösen Infusion (IVIG) BT090 sowie der Verträglichkeit undSicherheit von steigenden Infusionsgeschwindigkeiten (Teil B) beiPatienten mit primären Immundefekten (PID)

• Conditions: Primary immunodeficiency disease (PID); MedDRA version: 13.1Level: LLTClassification code 10010509Term: Congenital hypogammaglobulinemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-019249-25-HU
• Lead Sponsor: Biotest AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-06
• Last Update Posted: 8 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>Analyses of the pharmacokinetic parameters will be performed for the PK analysis set.<br>- Tolerability and safety of escalating infusion rates (PART B)<br>Analyses of the tolerability of escalating infusion rates will be performed for the safety set.<br>;Timepoint(s) of evaluation of this end point: Part A: about 3 months/first 3 infusions, PK at 3rd infusion<br>Part B: about 6 months/ 4th-6th infusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety<br>-number of AEs temorally associated with the infusion (occuring during infusion or within 72 hours after end of infusion)<br>-number of all other adverse events including safety laboratory parameters<br>-vital signs (change from initial/pre-infusion values)<br>body temperature<br>blood pressure<br>pulse rate;Timepoint(s) of evaluation of this end point: 6 months