Study of Octanorm Subcutaneous IG in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial

Primary Immunodeficiency Disease Clinical Trial

Official title:
Clinical Phase III Study to Monitor the Safety, Tolerability and Efficacy of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial

Status Completed

Clinical Trial Summary

Patients will be followed from the time of completion of the SCGAM 01 trial until octanorm becomes commercially available in the USA, until the sponsor decides to terminate the trial, or until a patient's treatment duration of 2.5 years is reached (whichever occurs first).

Clinical Trial Description

The study is a prospective, open-label, non-controlled, single-arm, multicentre phase III study. Patients will be followed from the time of completion of the SCGAM 01 trial until octanorm becomes commercially available in the USA, until the sponsor decides to terminate the trial, or until a patient's treatment duration of 2.5 years is reached (whichever occurs first). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02627300
Study type	Interventional
Source	Octapharma
Contact
Status	Completed
Phase	Phase 3
Start date	March 2016
Completion date	September 5, 2019

View Details

See also
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