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Study of Octanorm Subcutaneous IG in Patients With PID

Primary Immune Deficiency Disorder Clinical Trial

Official title:
Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases

Clinical Trial Summary

This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections (SBI) compared with historical control data and to evaluate the pharmacokinetic (PK) characteristics of octanorm.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01888484
Study type Interventional
Source Octapharma
Contact
Status Completed
Phase Phase 3
Start date March 2014
Completion date June 9, 2020
View Details
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