Clinical trials: sponsored by Octapharma
Chronic Lymphocytic Leukemia, Hypogammaglobulinemia
Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia
- Trial name
- NCT04502030
- Testing
- Panzyga
- Where
- 84 sites in United States, Czechia and 10 more
- Volunteers
- 247 people
- Sponsor
- Octapharma
Hypogammaglobulinemia, Autoimmune Conditions
Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic…
- Conditions
- Hypogammaglobulinemia, Autoimmune Conditions, Rheumatic Conditions, Infections
- Trial name
- NCT07220915
- Testing
- Panzyga, 10% Intravenous Solution
- Where
- 25 sites in United States, Bulgaria and 5 more
- Volunteers
- 360 people
- Sponsor
- Octapharma
Traumatic Hemorrhage, Coagulopathy
Factor In the Initial Resuscitation of Severe Trauma 2 Patients
Injury is the leading cause of death for people between the ages of 1-44. This is especially true in trauma patients who have bleeding complications.
- Conditions
- Traumatic Hemorrhage, Coagulopathy, Massive Hemorrhage
- Trial name
- FiiRST-2 (NCT04534751)
- Testing
- Fibrinogen + PCC, Frozen Plasma
- Where
- 6 sites in Canada
- Volunteers
- 142 people
- Sponsor
- University Health Network, Toronto
Severe Hemophilia A
Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A
This Phase 1/2 study will be a dose escalation study in adults in 5 cohorts (named cohorts 1, 2, 3, 5 and 6), with the main purpose to assess the safety of subcutaneous injection of OCTA101 (a human-cl rhFVIII and recombinant…
- Trial name
- NCT04046848
- Testing
- OCTA101
- Where
- Bulgaria
- Volunteers
- 36 people
- Sponsor
- Octapharma
Acute Hereditary Angio Edema
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with…
- Trial name
- NCT06361537
- Testing
- OCTA-C1-INH
- Where
- 25 sites in United States, Albania and 11 more
- Volunteers
- 124 people
- Sponsor
- Octapharma
Congenital Antithrombin Deficiency
Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
The goal of this study is to assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under when they receive Atenativ for surgical…
- Trial name
- NCT04918173
- Testing
- Atenativ
- Where
- 30 sites in United States, Armenia and 12 more
- Volunteers
- 38 people
- Sponsor
- Octapharma
Acquired Antithrombin Deficiency
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating…
- Trial name
- NCT06096116
- Testing
- Human plasma derived antithrombin
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 120 people
- Sponsor
- Octapharma
Hemophilia A
Treatment of Hemophilia A Patients With FVIII Inhibitors
This is a non-interventional, multicenter, observational, international study in male persons with haemophilia A who have developed inhibitors to any replacement coagulation factor VIII (FVIII) product.
- Trial name
- MOTIVATE (NCT04023019)
- Testing
- Nuwiq, Octanate, Wilate
- Where
- 2 sites in United States, Germany
- Volunteers
- 120 people
- Sponsor
- Emory University
Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk
Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
- Trial name
- NCT06429787
- Testing
- Balfaxar, Kcentra
- Where
- United States
- Volunteers
- 3,574 people
- Sponsor
- Octapharma
Primary Immune Deficiency
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases
- Trial name
- NCT04640142
- Testing
- Newnorm
- Where
- 23 sites in United States, Germany and 5 more
- Volunteers
- 50 people
- Sponsor
- Octapharma
Pediatric Chronic Inflammatory Demyelinating Polyneuropathy
Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
- Trial name
- NCT04929236
- Testing
- Panzyga
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Octapharma
Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy
The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated…
- Trial name
- NCT06599697
- Testing
- Intravenously administered pooled human immunoglobulin (IVIG)
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Alabama at Birmingham
VWD - Von Willebrand's Disease
Effectiveness and Tolerability of Eqwilate in Real-life Conditions
MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study
- Trial name
- NCT04106908
- Testing
- Eqwilate
- Where
- 9 sites in France
- Volunteers
- 38 people
- Sponsor
- Octapharma
Acute Major Bleeding
Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate…
- Trial name
- NCT04867837
- Testing
- Octaplex
- Where
- 63 sites in United States, Austria and 11 more
- Volunteers
- 100 people
- Sponsor
- Octapharma
Haemophilia A
Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally…
- Trial name
- Protect-NOW (NCT03695978)
- Where
- 59 sites in United States, Argentina and 16 more
- Volunteers
- 200 people
- Sponsor
- Octapharma
Hemophilia A
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
- Trial name
- NCT05936580
- Testing
- Nuwiq
- Where
- 16 sites in United States, Finland and 8 more
- Volunteers
- 28 people
- Sponsor
- Octapharma
Severe Hemophilia A
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
- Trial name
- NuPOWER (NCT05935358)
- Testing
- Nuwiq
- Where
- 18 sites in United States, Croatia and 9 more
- Volunteers
- 28 people
- Sponsor
- Octapharma
Primary Immune Deficiency Disorder, Secondary Immune Deficiency
Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.
This study will assess the relative safety, tolerability, and participant satisfaction in participants using the rapid manual push method with Cutaquig®.
- Trial name
- NCT04354129
- Testing
- Cutaquig®
- Where
- Canada
- Volunteers
- 36 people
- Sponsor
- University of Alberta
Complement Deficiency, Antibody Deficiency
Systematic Search for Primary Immunodeficiency in Adults With Infections
Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections …
- Conditions
- Complement Deficiency, Antibody Deficiency, Chronic Sinus Infection, Meningitis, Bacterial
- Trial name
- SPIDAC (NCT02972281)
- Testing
- Immunological diagnosis tests
- Where
- 19 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Lille
Pediatric HD, Bleeding
Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in…
- Trial name
- NCT04376762
- Testing
- Fibrinogen, Cryoprecipitate
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Virginia