These trials completed more than 12 months ago and should have reported results. Some have, some have not.

These trials are not yet due to report results: some are ongoing, some completed within the past 12 months.

These trials have problematic data on the registry. Details why »

Status Trial ID Title Completion date Category
Reported results 2005-001426-84 CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE 2009-10-12 due-trials
Reported results 2005-003552-35 Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults 2008-09-15 due-trials
Ongoing, reported early 2005-004435-22 INCIDENCE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEAMOPHILIA A TREATED WITH OCTANATE not-yet-due
Completed, but no date, and reported results 2006-002857-54 International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD) bad-data
Ongoing, reported early 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. not-yet-due
Listed as ongoing, but also has a completion date and reported results 2007-002611-27 Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) 2010-09-30 bad-data
Reported results 2007-007134-19 Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer’s ... 2010-09-21 due-trials
Reported results 2008-000795-24 Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate 2017-10-16 due-trials
Reported results 2008-001563-11 Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treat... 2012-09-18 due-trials
Completed, but no date, and reported results 2008-001910-25 Pharmacokinetics of WILATE® and Haemate® P in von Willebrand type 3 patients - a prospective, randomised, controlled, open-labelled, 2-arm cross-over study bad-data
Reported results Terminated 2008-004579-22 A prospective, multicentre, open label, exploratory study to investigate the ability of the Heidelberg Assay Panel and the B-Cell /Antibody response panel to predict the clinical effect of Octagam 5% ... 2011-03-31 due-trials
Reported results 2009-011055-43 Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A 2012-01-31 due-trials
Trial is partly outside EEC, and reported results 2009-011434-10 CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES bad-data
Listed as ongoing, but also has a completion date and reported results 2009-014589-24 Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia 2014-01-29 bad-data
Not reported Terminated 2009-017805-13 "PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN P... 2011-11-07 due-trials
Reported results 2010-018644-14 PROSPECTIVE CLINICAL STUDY IN CHILDREN WITH SEVERE HAEMOPHILIA A TO INVESTIGATE CLINICAL EFFICACY, IMMUNOGENICITY, PHARMACOKINETICS, AND SAFETY OF HUMAN-CL RHFVIII 2012-11-06 due-trials
Reported results 2010-021162-30 Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate) In Subjects With Inherited Type 3 Von Willebrand Di... 2014-04-08 due-trials
Reported results 2010-023242-69 Clinical Study to Investigate the Long-Term Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients with Severe Haemophilia A – Extension Study to GENA-01 2012-08-30 due-trials
Reported results 2011-001785-17 Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII 2016-05-13 due-trials
Listed as ongoing, but also has a completion date and reported results 2011-002403-15 A prospective, controlled, randomised, cross-over study investigating the pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/ RiaSTAPTM in subjects ... 2015-01-19 bad-data
Reported results 2011-002419-27 Prospective, open-label, uncontrolled, Phase III study to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in sub... 2018-01-28 due-trials
Trial is outside EEC, and reported results 2011-005015-82 Clinical study to evaluate the safety and tolerability of immunoglobulin intravenous (human) 10% (NewGam) administered at high infusion rates to patients with primary immunodeficiency diseases (extens... bad-data
Reported results 2012-000792-16 “CLINICAL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF OCTAGAM 5% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES” 2013-03-12 due-trials
Reported results 2012-000796-16 PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA 2013-03-29 due-trials
Listed as ongoing, but also has a completion date and reported results 2012-002554-23 Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII in Previously Untreated Patients with Severe Haemophilia A 2020-03-24 bad-data
Reported results 2012-005086-12 Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. 2016-02-25 due-trials
Reported results 2013-001556-35 Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of individually tailored prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemop... 2015-01-23 due-trials
Reported results 2013-003877-87 CLINICAL PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, TOLERABILITY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM 16.5%) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES ... 2020-06-09 due-trials
Reported results 2013-003997-28 Extension Study for Patients who completed GENA-05 (NuProtect) – to Investigate Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII 2018-12-27 due-trials
Reported results 2014-002986-30 Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of personalized prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A 2018-09-05 due-trials
Reported results 2014-003746-27 A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two differ... 2017-12-11 due-trials
Trial is outside EEC, and reported results 2014-005115-16 Prospective, open-label, uncontrolled, Phase III study to assess the efficacy, safety, and pharmacokinetics of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and a... bad-data
Reported results 2015-005443-14 Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo... 2019-11-05 due-trials
Ongoing 2016-002649-41 A Phase III, randomized, double-blind, multicenter study to assess the efficacy and safety of OCTAPLEX, a four-factor prothrombin complex concentrate (4F-PCC), compared to the 4F-PCC Beriplex® P/N (Kc... not-yet-due
Listed as ongoing, but also has a completion date and reported results 2016-002902-37 PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS 2020-01-21 bad-data
Reported results 2016-003681-34 Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Patients with Severe Hemophilia A Badanie kliniczne w celu zbadania farmako... 2018-03-29 due-trials
Reported results 2016-003749-27 Prospective, Randomised, Controlled Phase 2 Study Investigating the Haemostatic Efficacy and Safety of Fibrinogen Concentrate (Octafibrin) and Cryoprecipitate as Fibrinogen Supplementation Sources in ... 2018-07-20 due-trials
Trial is outside EEC, and reported results 2017-001531-40 Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Pediatric Patients with Severe Hemophilia A bad-data
Reported results 2017-002710-31 DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. 2018-12-15 due-trials
Exempt 2018-002776-40 Phase 1/2 study to assess the safety and pharmacokinetic of subcutaneous injection of OCTA101 in previously treated adult patients with severe hemophilia A not-yet-due
Other 2018-004675-13 CLINICAL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF WILATE DURING PROPHYLAXIS IN PREVIOUSLY TREATED PATIENTS WITH VON WILLEBRAND DISEASE (VWD) not-yet-due
Trial is outside EEC, and reported results 2018-004686-13 An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of M... bad-data
Completed, report not yet due 2019-001693-28 Prospective, open-label, single arm, multicenter, pharmacokinetic, and safety study of a single dose intravenous human plasma-derived C1 Esterase Inhibitor (C1-INH) concentrate in patients with congen... 2021-02-17 not-yet-due
Trial is outside EEC 2019-002999-13 CLINICAL PHASE 3 STUDY TO MONITOR THE SAFETY, TOLERABILITY, AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (CUTAQUIG®) ADMINISTERED AT MODIFIED DOSING REGIMENS IN PATIENTS WITH PRIMARY IMMUNODEFICI... bad-data
Trial is outside EEC 2019-004063-49 Post-Marketing Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients with Chronic Immune Thrombocytopenia (ITP) bad-data
Ongoing 2019-004375-40 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... not-yet-due
Trial is outside EEC, and reported results 2020-000650-10 An open-label, multicenter, Post-Marketing Requirement study to investigate the safety and tolerability of octaplas™ in the management of pediatric patients who require therapeutic plasma exchange. bad-data
Trial is outside EEC 2020-000867-21 A Superiority Study To Compare The Effect of Panzyga Versus Placebo in Patients with Pediatric Acute-onset Neuropsychiatric Syndrome bad-data
Trial is outside EEC 2020-002482-34 Efficacy and safety of Octagam 10% therapy in COVID-19 patients with severe disease progression bad-data
Exempt 2020-004734-37 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 prim... not-yet-due
Trial is outside EEC 2021-003200-40 Multicenter, Prospective, Parallel Group, Open-label, Randomized Phase III Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Poly... bad-data