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
Status	Clinical Trial	Phase
Recruiting	`NCT03677557` - Safety, Tolerability, Patient Satisfaction and Cost of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment	Phase 4
Completed	`NCT02810444` - Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID	Phase 3
Enrolling by invitation	`NCT01150240` - Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland	N/A
Recruiting	`NCT04944979` - Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)	Phase 3
Not yet recruiting	`NCT03252548` - Pediatric Primary Immunodeficiency Disease (PID) in China	N/A
Completed	`NCT03961009` - Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients	Phase 3
Completed	`NCT04842643` - An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease	Phase 3
Not yet recruiting	`NCT06089122` - Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG	Phase 3
Not yet recruiting	`NCT06150833` - Efficacy and Safety and Pharmacokinetics of Boya IVIG	Phase 3