EUCTR2011-005015-82-Outside-EU/EEA
Active, not recruiting
Not Applicable
Clinical study to evaluate the safety and tolerability of immunoglobulin intravenous (human) 10% (NewGam) administered at high infusion rates to patients with primary immunodeficiency diseases (extension of study NGAM 01)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Octapharma AG
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Completion of the main study NGAM 01,
- •At each of the last three infusions in the main study NGAM 01, administration of NewGam at the maximum infusion rate of 0\.08 mL/kg/min and without the need for premedication,
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 8
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Any condition or circumstance that would have led to the exclusion of the subject from the NGAM 01 study,
- •Administration of any immunoglobulin infusion other than NewGam between conclusion of the NGAM 01 study and the beginning of the present study,
- •A deviation of the subject’s treatment interval of more than 7 days between the last infusion of NewGam in the NGAM 01 study and the first infusion of NewGam in the present study.
Outcomes
Primary Outcomes
Not specified
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