| Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer |
2014-000392-33: Comparing fixed dosing versus individualized dosing of prothrombine complex concentrate in treating (possible) bleeding in users of vitamin K antagonists. |
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| Ongoing | 4 | 480 | Europe | Concentrate for solution for injection, Cofact (Sanquin) Beriplex (CSL Behring) Octaplex (Octapharma) | University Medical Center Groningen, University Medical Center Groningen, Sanquin | Major bleeding complications of vitamin K antagonists, Major bleeding in patients using vitamin K antagonists (acenocoumarol or phenprocoumon), Diseases [C] - Injuries, poisonings, and occupational diseases [C21] | | | | |
2007-000602-73: Efficacy and Safety of two doses regimens of Octaplex in patients with cerebral haemorrhage related to oral anticoagulant therapy: A phase IV, prospective, randomised, open-label study. |
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| Ongoing | 4 | 60 | Europe | OCTAPLEX, OCTAPLEX | OCTAPHARMA AG | Traitement des saignements et prophylaxie péri-opératoire des accidents hémorragiques en cas de déficit acquis en facteurs de coagulation du complexe prothrombique, notamment induit par les anti-vitamines K, quand une correction urgente du déficit est requise | | | | |
| 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 |
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| 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. |
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| 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 |
2008-000795-24: Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate |
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| Ongoing | 4 | 5 | Europe | Wilate, Wilate | Octapharma AG | von Willebrand disease | | | | |
| Active, not recruiting | 3 | 12 | Europe, US, RoW | wilate | Octapharma | Von Willebrand Disease | 12/24 | 12/24 | | |
EMPOWER, NCT06205095: A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD |
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| Not yet recruiting | 3 | 20 | NA | Lyophilized concentrate of human coagulation von Willebrand Factor and factor VIII, Wilate, Placebo | Unity Health Toronto | Von Willebrand Diseases | 09/26 | 09/26 | | |
NCT04106908: Effectiveness and Tolerability of Eqwilate in Real-life Conditions |
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| 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 |
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| Recruiting | N/A | 200 | Europe, Canada, US, RoW | | Octapharma | Haemophilia A | 06/30 | 06/30 | | |
| Gammanorm (human immune globulin subcutaneous) / Octapharma |
2017-002024-24: Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathy Standardiseret aftrapning af dosis af subkutan immunglobulin hos patienter med kronisk inflammatorisk nervebetændelse |
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| Ongoing | 4 | 60 | Europe | Gammanorm, Hizentra, Subcuvia, Solution for injection/infusion, Gammanorm, Hizentra, Subcuvia | Aarhus Unversity Hospital, Danish Regions | Chronic inflammatory demyelinating polyneuroapthy Kronisk inflammatorisk demyeliniserende polyneuropati, Chronic inflammatory polyneuropathy Kronisk immunmedeieret nervebetændelse, Diseases [C] - Nervous System Diseases [C10] | | | | |
| Recruiting | 2 | 30 | Canada | subcutaneous immunoglobulin (SCIG), Cuvitru, intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG), Gammanorm + Cuvitru | University Health Network, Toronto | Myasthenia Gravis | 06/23 | 12/23 | | |
NCT05986734: Evaluation of Subcutaneous Immunoglobulin Product Cutaquig in Terms of Safety and Efficacy in the Treatment of Patients With Primary Immunodeficiencies |
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| Recruiting | N/A | 100 | RoW | Cutaquig, subcutaneous immunoglobulin, Octapharma | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Primary Immunodeficiency Diseases (PID) | 07/23 | 12/23 | | |
NCT04354129: Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency. |
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| 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. |
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| 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 |
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| 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] | | | | |
2008-008378-29: A survey on the success of inhibitor elimination using individualized concentrate selection and controlled immune tolerance induction |
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| Ongoing | 3 | 15 | Europe | FACTANE 100UI/ml, KOGENATE Bayer 250 UI, HELIXATE NexGen 250 UI, REFACTO 250 UI, ADVATE 250 UI, OCTANATE 500 UI, KOGENATE Bayer 500 UI, KOGENATE Bayer 1000 UI, HELIXATE NexGen 500 UI, HELIXATE NexGen 1000 UI, REFACTO 500 UI, REFACTO 1000 UI, REFACTO 2000 UI, ADVATE 500 UI, ADVATE 1000 UI, ADVATE 1500 UI, OCTANATE 1000 UI, FACTANE 100UI/ml, KOGENATE Bayer 250 UI, HELIXATE NexGen 250 UI, REFACTO 250 UI, ADVATE 250 UI, OCTANATE 500 UI, KOGENATE Bayer 500 UI, KOGENATE Bayer 1000 UI, HELIXATE NexGen 500 UI, HELIXATE NexGen 1000 UI, REFACTO 500 UI, REFACTO 1000 UI, REFACTO 2000 UI, ADVATE 500 UI, ADVATE 1000 UI, ADVATE 1500 UI, OCTANATE 1000 UI | CHU de Saint-Etienne | patients with haemophilia A | | | | |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
2011-001982-42: A study of the effect of antiretroviral therapy and immunoglobulin on the HIV reservoir in Acute HIV Infection. |
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| Ongoing | 4 | 10 | Europe | Octagam, Solution for infusion, Octagam | Guy's & St. Thomas' NHS Foundation Trust, Guy's & St. Thomas' Charity | Acute HIV Infection, Acute HIV Infection, Diseases [C] - Immune System Diseases [C20] | | | | |
NCT04616001: IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation |
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| Not yet recruiting | 4 | 10 | US | IVIG, Octagam | Sharp HealthCare | Covid19, SARS-CoV Infection | 06/21 | 06/21 | | |
2012-005086-12: Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin |
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| Ongoing | 3 | 81 | Europe | Rebif 44 micrograms, Betaferon 250 microgram/ml, Extavia 250 microgram/ml, Octagam 50 mg/ml, Copaxone 20 mg/ml, Rebif 44 micrograms, Betaferon 250 microgram/ml, Extavia 250 microgram/ml, Octagam 50 mg/ml, Copaxone 20 mg/ml, Rebif 44 micrograms, Betaferon 250 microgram/ml, Extavia 250 microgram/ml | Octapharma AG, Octapharma AG | relapsing multiple sclerosis | | | | |
| 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] | | | | |
| Recruiting | 3 | 272 | Europe | Neofordex®, Dexamethasone, Intravenous immunoglobulins, Tegeline®, Clayrig®,, Gammagard®,, Octagam®,, Privigen®,, Other IgIV patent medicine | Assistance Publique - Hôpitaux de Paris | Immune Thrombocytopenia (ITP) | 04/25 | 10/26 | | |
| 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 |
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| 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) |
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| 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) |
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| 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) |
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| 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 |
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| Recruiting | 3 | 30 | US | Panzyga | Octapharma | Pediatric Chronic Inflammatory Demyelinating Polyneuropathy | 06/26 | 06/26 | | |
NCT04153422: IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies |
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| Recruiting | 2 | 20 | US | Panzyga IVIG, Placebo | Henry Ford Health System, Octapharma USA, Inc. | Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy, Inflammatory Polyneuropathy, Immune-Mediated Neuropathy | 12/26 | 04/27 | | |
| Albunorm (human albumin) / Octapharma |
2017-003687-12: Effect of infusion rate of hyperoncotic albumin on fluid balance in the body Hur mycket betyder dropphastigheten av 20% albumin för vätskestatus i kroppen. |
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| Ongoing | 4 | 12 | Europe | Human albumin, Solution for infusion, Albunorm 200 g/l | Region Ostergotland, Region Ostergotland | Healthy adult volunteers Fluid mobilisation. Friska försökspersoner. Vätskemobilisering., Healthy individuals. To investigate if oedema fluid can be mobilised from the tissues to the blood and excreted as urine. This is of interest for patients with oedema. Friska försökspersoner Undersökning med målsättning om grad av vätskemobilisering från vävnad till blod och utsöndring som urin. Detta är av intresse för patienter med ödem., Body processes [G] - Physiological processes [G07] | | | | |
2019-004733-17: Plasma exchange by albumin replacement in Adrenomyeloneuropathy Estudio del recambio plasmático de albúmina en pacientes con adrenomieloneuropatía |
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| Not yet recruiting | 2 | 5 | Europe | Albumin, Solution for solution for infusion, Albunorm® 5%, | Aurora Pujol Onofre, Albus Award Grifols Scientific Awards | Adrenomyeloneuropathy Adrenomieloneuropatia (AMN), Adrenomyeloneuropathy Adrenomieloneuropatia (AMN), Diseases [C] - Nervous System Diseases [C10] | | | | |
| Fibryga (fibrinogen concentrate (human)) / Octapharma |
NCT04376762: Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients |
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| Completed | 4 | 30 | US | Fibrinogen, Fibrinogen Concentrate (Human) Injection [Fibryga], Cryoprecipitate | University of Virginia, Octapharma | Pediatric HD, Bleeding | 03/23 | 05/23 | | |
2016-003749-27: Fibrinogen (blood protein) supplementation in patients that have developed fibrinogen deficiency during surgery. |
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| Ongoing | 2 | 55 | Europe | Octafibrin, Cryoprecipitate, Powder for solution for injection, Concentrate for solution for injection/infusion | Octapharma AG | The sequence of events culminating in Pseudomyxoma peritonei (PMP) is thought to involve growth of an appendiceal adenoma with distension of the appendix by mucus and mucinous tumour cells. The appendix eventually ruptures. Patients undergoing the PMP surgery develop a coagulopathy predominantly characterised by reduced levels of fibrinogen, resulting in reduced whole blood clot firmness., Surgery performed on a cancer (tumour) in the appendix, causes decreased levels of blood clotting factor (fibrinogen)., Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | | | | |
| 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 |
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| Not yet recruiting | 3 | 120 | NA | Human plasma derived antithrombin, Placebo | Octapharma | Acquired Antithrombin Deficiency | 09/26 | 09/26 | | |
