Clinical trials: sponsored by Octapharma
Primary Immunodeficiency Disease
High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main…
- Trial name
- NGAM-05 (NCT01313507)
- Testing
- NewGam
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Octapharma
Primary Immunodeficiency Diseases
A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam.
- Trial name
- NCT01012323
- Testing
- NewGam
- Where
- 7 sites in United States
- Volunteers
- 51 people
- Sponsor
- Octapharma
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP
NewGam (current working title for a new IGIV formulation) is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV).
- Trial name
- POINT (NCT01225276)
- Testing
- NewGam 10%
- Volunteers
- 2 people
- Sponsor
- Octapharma
Aortic Aneurysm, Thoracic, Endothelial Dysfunction
Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)
Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated pilot trial
- Trial name
- VIPER-OCTA (NCT02253082)
- Testing
- OctaplasLG®, Fresh frozen plasma
- Where
- Denmark
- Volunteers
- 44 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Chronic Inflammatory Demyelinating Polyneuropathy, Multifocal Motor Neuropathy
Immunoglobulin Dosage and Administration Form in CIDP and MMN
The aim of this study is to evaluate development of hemolysis and the variation in isokinetic muscle strength in two groups of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) or multifocal motor neuropathy…
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, Multifocal Motor Neuropathy, Hemolytic Anemia
- Trial name
- NCT02111590
- Testing
- Immunoglobulins
- Where
- Denmark
- Volunteers
- 36 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Prevent Bleeding in Major Surgery
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
- Trial name
- WONDERS (NCT01365546)
- Testing
- human VWF/FVIII concentrate
- Where
- 15 sites in United States, Bulgaria and 7 more
- Volunteers
- 30 people
- Sponsor
- Octapharma
Immune Thrombocytopenic Purpura
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries.
- Trial name
- NCT00426270
- Testing
- Octagam 10%
- Where
- Austria
- Volunteers
- 116 people
- Sponsor
- Octapharma
Comparison of Octaplas LG and Octaplas SD
A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters.
- Trial name
- NCT01063595
- Testing
- Octaplas LG, Octaplas SD
- Where
- Austria
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Octapharma
Alzheimer's Disease
Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease
This study evaluated the effect of 6 or 12 infusions of different doses of octagam (intravenous immunoglobulin [IVIG]) 10% on the reduction of amyloid beta peptide (Aβ) in cerebral spinal fluid (CSF) and on the increase of Aβ in…
- Trial name
- NCT00812565
- Testing
- octagam 10%
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Octapharma
Rasmussen Encephalitis
Efficacy of Tacrolimus and I.V.-Immunoglobulins in Rasmussen Encephalitis
Rasmussen encephalitis (RE) is a rare but severe chronic inflammatory brain disease of unknown origin affecting one brain hemisphere. It is usually accompanied by intractable epilepsy.
- Trial name
- NCT00545493
- Testing
- Tacrolimus, i.v. immunoglobulins
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital, Bonn