| Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer |
| Recruiting | 4 | 350 | Canada | Fibrinogen + PCC, Fibryga + Octaplex, Frozen Plasma | University Health Network, Toronto, Sunnybrook Health Sciences Centre, Octapharma, Canadian Institutes of Health Research (CIHR), Canadian Institute for Military and Veteran Health Research Defense Research & Development Canada | Traumatic Hemorrhage, Coagulopathy, Massive Hemorrhage | 12/23 | 01/24 | | |
| Recruiting | 3 | 260 | Europe, US, RoW | Octaplex | Octapharma, Octapharma AG | Acute Major Bleeding | 12/24 | 12/24 | | |
FARES-2, NCT05523297: Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery |
|
|
| Recruiting | 3 | 500 | Canada, US | Octaplex, Frozen Plasma Product, Human | Octapharma | Bleeding Cardiac Surgery Patients | 08/24 | 08/24 | | |
2018-003041-41: Comparisons of two different blood products (callled fresh frozen plasma and prothrombin complex concentrate) in patients who are undergoing cardiac surgery and who develop major bleeding that requires treatment with blood product - a pilot randomised control trial. |
|
|
| Not yet recruiting | 2 | 50 | Europe | OCTAPLEX, LG-Octaplas, Concentrate and solvent for solution for infusion, Solution for infusion, OCTAPLEX, LG-Octaplas | Queen Mary University of London, British Heart Foundation | Major bleeding during cardiac surgery not related to vitamin K antagonists, Bleeding during cardiac surgery, Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | | | | |
| Wilate (human factor VIII/von Willebrand factor) / Octapharma |
| Active, not recruiting | 3 | 12 | Europe, US, RoW | wilate | Octapharma | Von Willebrand Disease | 12/24 | 12/24 | | |
NCT04106908: Effectiveness and Tolerability of Eqwilate in Real-life Conditions |
|
|
| Recruiting | N/A | 47 | Europe | Eqwilate | Octapharma | VWD - Von Willebrand's Disease | 09/21 | 09/21 | | |
| Recruiting | N/A | 110 | US | Use of a postpartum diary and additional blood draws, VWF replacement therapy with Wilate, Tranexamic acid, Use of a postpartum diary and additional blood draws. | Bloodworks, Mary M. Gooley Hemophilia Center, Ergomed, Octapharma | Von Willebrand Diseases | 06/23 | 06/23 | | |
Protect-NOW, NCT03695978: Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients |
|
|
| Recruiting | N/A | 200 | Europe, Canada, US, RoW | | Octapharma | Haemophilia A | 06/30 | 06/30 | | |
| Gammanorm (human immune globulin subcutaneous) / Octapharma |
NCT04354129: Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency. |
|
|
| Recruiting | N/A | 30 | Canada | Cutaquig®, Immunoglobulin (human) subcutaneous 16.5% Solution for injection (165 mg/mL) | University of Alberta, Octapharma | Primary Immune Deficiency Disorder, Secondary Immune Deficiency | 06/24 | 06/24 | | |
| Octanate (human Factor VIII/von Willebrand Factor) / Octapharma |
2014-005435-14: Combination treatment with DDAVP and factor VIII clotting factor concentrates in patients with mild haemophilia A. Combinatiebehandeling van DDAVP en factor VIII-concentraten in patiënten met milde hemofilie A. |
|
|
| Ongoing | 4 | 60 | Europe | Solution for injection/infusion, Powder and solvent for solution for injection, Minrin, Octostim, Advate, Kogenate Bayer, Helixate NexGen, ReFacto AF, Aafact, Octanate, NovoEight | Erasmus University Medical Center, ZonMw, Ferring BV, Erasmus University Medical Centre | Mild hemophilia A patients with a FVIII plasma levels above 0.05 IU/mL. Milde hemofilie A-patiënten, A clotting disorder in which clotting factor VIII is deficient, which can cause bleeding. In this study we will look at patients with the mild form. Een stollingsstoornis waarin het gehalte van stollingsfactor VIII is verlaagd. Hierdoor kunnen bloedingen veroorzaakt worden. In deze studie kijken we naar patiënten met een milde vorm., Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
2019-003427-38: An international investigator trial to capture different approaches in the treatment of Hemophilia A Patients With FVIII Inhibitors |
|
|
| Ongoing | 4 | 120 | Europe, RoW | Octanate, Wilate, Nuwiq, Hemlibra, NovoSeven, Powder and solvent for solution for injection, Solution for injection, Octanate, Wilate, Nuwiq, Hemlibra, FEIBA NF 500 E/1000 E, NovoSeven | HZRM – Hämophilie-Zentrum Rhein Main GmbH, Octapharma AG | Inhibitor-Positive patients with Haemophilia A, Haemophilia A in patients who have developed inhibitors to any FVIII product., Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
| Recruiting | N/A | 120 | Europe, US | Nuwiq, Octanate, Wilate, Emicizumab, Hemlibra, Recombinant factor VIIa (rFVIIa), NovoSeven, Activated prothrombin complex concentrate (aPCC), FEIBA | Emory University, Octapharma | Hemophilia A | 12/28 | 06/29 | | |
| Nuwiq (simoctocog alfa) / Octapharma |
NCT05936580: Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery |
|
|
| Not yet recruiting | 4 | 28 | Europe, RoW | Nuwiq | Octapharma | Hemophilia A | 12/25 | 12/25 | | |
NuPOWER, NCT05935358: Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study |
|
|
| Recruiting | 4 | 28 | Europe, RoW | Nuwiq | Octapharma | Severe Hemophilia A | 12/25 | 12/25 | | |
| Withdrawn | 3 | 2 | US | Nuwiq (low dose protocol), Simoctocog alfa, HEMLIBRA, Emicizumab, ACE910, and RO5534262, Nuwiq (Atlanta protocol) | Emory University, Genentech, Inc. | Hemophilia A | 01/23 | 01/23 | | |
NCT04592692: A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip |
|
|
| Recruiting | 2 | 20 | RoW | PEGylated Liposome (PEGLip), Simoctocog alfa | Ascension Healthcare Development Limited | Hemophilia A With Inhibitor | 02/22 | 05/22 | | |
2018-002776-40: Study to assess the safety and pharmacokinetic of subcutaneous injection of OCTA101 in previously treated adult patients suffering from severe hemophilia A |
|
|
| Not yet recruiting | 1/2 | 40 | Europe | OCTA101 (human-cl rhFVIII and recombinant human von Willebrand Factor fragment dimer), Nuwiq, Powder and solution for solution for injection, Nuwiq | Octapharma AG, Octapharma AG | Severe hemophilia A, Haemophilia A patients have insufficient levels of an important factor (factor VIII) in their blood. Factor VIII is important to stop bleeding., Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | | | | |
| Octagam (intravenous normal human immunoglobulin) / Octapharma |
| Ongoing | 3 | 262 | Europe | Prednisolone (Tablet 1mg), Prednisolone (Soluble Tablet 5mg), Prednisolone (Oral Solution 10mg/ml), Human Normal Immunoglobulin (IVIg 100mg/ml), Aspirin (Dispersible Tablet 75mg), Aspirin (Tablets 300mg), Prednisolone (Tablet 5mg), Prednisolone (Tablet 10mg), Prednisolone (Tablet 2.5mg), Prednisolone (Tablet 20mg), Prednisolone (Tablet 25mg), Prednisolone (Tablet 30mg), Methylprednisolone (500mg), Methylprednisolone (1000mg), Human Normal Immunoglobulin (IVIg 50mg/ml), Aspirin (Tablet 75mg), Methylprednisolone (40mg), Methylprednisolone (125mg), Methylprednisolone (2g), B01AC06, Tablet, Soluble tablet, Oral solution, Solution for injection/infusion, Dispersible tablet, Powder and solvent for solution for injection/infusion, Powder for injection, Asaflow (80mg), Aspirine (100mg), Aspegic 100mg, Cardioaspirine (100mg), Solu-Medrol S.A.B. (40mg), Octagam (50 mg/ml) solution for infusion, Octagam 10% solution for infusion, Privigen 100 mg/ml solution for infusion, Iqymune (100mg/mL), Okrido 6mg/ml drank | MRC CTU at UCL, Medical Research Council Clinical Trials Unit at University College London, UNIVERSITY COLLEGE LONDON, MRC Clinical Trials Unit at University College London (UCL), Innovative Medicines Initiative 2 Joint Undertaking, Innovative Medicines Initiative 2, Innovative Medicine Initiative 2 Joint Undertaking | Kawasaki Disease, Kawasaki Disease, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
| ASP7317 / Octapharma, Astellas |
NCT03178149: A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration |
|
|
| Recruiting | 1 | 42 | US | ASP7317, tacrolimus, FK506, Prograf®, trimethoprim-sulfamethoxazole, TMP/SMX, Acyclovir, Nystatin | Astellas Institute for Regenerative Medicine | Age-Related Macular Degeneration | 01/26 | 01/26 | | |
| Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma |
NCT03866798 / 2019-004063-49: Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP) |
|
|
| Active, not recruiting | 4 | 20 | US | Panzyga | Octapharma | Chronic Immune Thrombocytopenia | 04/24 | 04/24 | | |
2019-004375-40: Study for the evaluatiion of Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia (“PRO-SID” study) Studie zur Ermittlung der Wirksamkeit und Sicherheit von Panzyga in der primären Infektionsprophylaxe bei Patienten mit chronischer lymphatischer Leukämie ("PRO-SID"-Studie) |
|
|
| Not yet recruiting | 3 | 450 | Europe, RoW | Panzyga, [NA], Solution for infusion, Panzyga | Octapharma Pharmazeutika Produktionsges.m.b.H., OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H., Octapharma Pharmazeutika Produktionsges.m.b.H. | Primary infection prophylaxis in patients with chronic lymphocytic leukemia (CLL) and secondary hypogammaglobulinemia, Prophylaxis to prevent infection in patients with a type of cancer that starts in bone marrow and then go into the blood, Diseases [C] - Cancer [C04] | | | | |
PROSID, NCT04502030: 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) |
|
|
| Recruiting | 3 | 240 | Europe, US, RoW | Panzyga, Placebo | Octapharma | Chronic Lymphocytic Leukemia, Hypogammaglobulinemia | 10/25 | 10/25 | | |
| Active, not recruiting | 3 | 70 | Europe, US | Panzyga, Placebo | Octapharma | Pediatric Acute-Onset Neuropsychiatric Syndrome | 06/24 | 06/24 | | |
NGAM-11, NCT04929236 / 2021-003200-40: Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients |
|
|
| Recruiting | 3 | 30 | US | Panzyga | Octapharma | Pediatric Chronic Inflammatory Demyelinating Polyneuropathy | 06/26 | 06/26 | | |
| Fibryga (fibrinogen concentrate (human)) / Octapharma |
NCT04376762: Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients |
|
|
| Completed | 4 | 30 | US | Fibrinogen, Fibrinogen Concentrate (Human) Injection [Fibryga], Cryoprecipitate | University of Virginia, Octapharma | Pediatric HD, Bleeding | 03/23 | 05/23 | | |
| Recruiting | N/A | 25 | Europe, RoW | Fibryga | Octapharma | Congenital Fibrinogen Deficiency | 10/27 | 10/27 | | |
| Atenativ (human antithrombin III) / Octapharma |
| Recruiting | 3 | 38 | Europe, US, RoW | Atenativ | Octapharma | Congenital Antithrombin Deficiency | 06/25 | 06/25 | | |
NCT06096116: 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 |
|
|
| Not yet recruiting | 3 | 120 | NA | Human plasma derived antithrombin, Placebo | Octapharma | Acquired Antithrombin Deficiency | 09/26 | 09/26 | | |
