An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID)

• Register: EUCTR
• Last refreshed on: 8 May 2012
• Main ID: EUCTR2010-019249-25-DE
• Date of registration: 14/05/2010
• Prospective Registration: Yes
• Primary sponsor: Biotest AG
• Public title: An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID)
• Scientific title: An open, prospective trial investigating pharmacokinetics and safety (Part A) of the human normal immunoglobulin for intravenous infusion (IVIG) BT090 and tolerability and safety of escalating infusion rates (Part B) in patients with primary immunodeficiency disease (PID)
• Date of first enrolment: 12/08/2010
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019249-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany, Hungary

Contacts

• Name: Clinical Trial Information
• Affiliation: Biotest AG

• Name: Clinical Trial Information
• Affiliation: Biotest AG

Key inclusion & exclusion 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:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Intervention(s)

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)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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

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.

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)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 6 months

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

Secondary ID(s)

981

Source(s) of Monetary Support

Biotest AG