Study to evaluate the safety of human immune globulin in patients withprimary immunodeficiency diseases.

• Conditions: primary immunodeficiency diseases; MedDRA version: 14.1Level: LLTClassification code 10049485Term: Bruton's agammaglobulinemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: LLTClassification code 10010112Term: Common variable immunodeficiencySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-005015-82-Outside-EU/EEA
• Lead Sponsor: Octapharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-10
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 20

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of NewGam when administered at infusion rates from 0.08 mL/kg/min (the maximum rate of in study NGAM-01) to 0.14 mL/kg/min.;Secondary Objective: To obtain a continued assessment of the effect of NewGam on quality-of-life (QoL) measures.;Primary end point(s): Occurrence of causally and/or temporally related Adverse Events;Timepoint(s) of evaluation of this end point: continuously, see protocol

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): quality of life;Timepoint(s) of evaluation of this end point: continuously, see protocol