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

Phase 3

Completed

• Conditions: Primary immunodeficiency (PID) diseases; Not Applicable; Certain disorders involving the immune mechanism

• Registration Number: ISRCTN11002924
• Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-16
• Study Completion: 2012-06-30
• Last Update Posted: 1 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Completion of the main study NGAM 01
2. 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
3. For adult patients: freely given written informed consent. For patients below the legal age of majority: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with the applicable approvals
4. For female patients of child-bearing potential, a negative result in a urine pregnancy test conducted at the screening visit
5. Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study

Exclusion Criteria

1. Any condition or circumstance that would have led to the exclusion of the subject from the NGAM 01 study
2. Administration of any immunoglobulin infusion other than NewGam between conclusion of the NGAM 01 study and the beginning of the present study
3. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified