These trials completed more than 12 months ago and should have reported results.

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
Listed as ongoing, but also has a completion date and reported results 2005-005697-71 “Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF–PFM): A Phase 3/4, prospective, controlled, randomized, multi-center Study to compare the efficacy and safety of continous infusi... 2015-12-09 bad-data
Reported results 2010-022726-33 BAX 326 (factor IX recombinante): Estudio de continuación sobre la evaluación de seguridad, inmunogenicidad y eficacia hemostática en pacientes tratados previamente portadores de hemofilia B grave (ni... 2017-06-29 due-trials
Reported results 2012-003221-19 BAX 930 (rADAMTS13) 2016-02-22 due-trials
Reported results 2013-001359-11 A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures 2016-09-25 due-trials
Reported results 2013-002236-24 A Phase 3b Continuation study of the Safety and Efficacy of PEGylated 2018-03-02 due-trials
Listed as ongoing, but also has a completion date and reported results 2014-000742-30 A phase 3 prospective, uncontrolled, multicenter study evaluating pharmacokinetics, efficacy, safety, and immunogenicity of BAX 855 (PEGylated full-length Recombinant FVIII) in previously treated pedi... 2015-10-23 bad-data
Reported results 2014-003575-38 A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE 2016-07-06 due-trials
Reported results 2014-005477-37 Phase 3, prospective, randomized, multi-center clinical study comparing the safety and efficacy of BAX 855 following PK-guided prophylaxis targeting two different FVIII trough levels in subjects with ... 2018-08-05 due-trials
Ongoing 2014-005496-87 A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), ... not-yet-due
Reported results 2015-000896-28 A Phase 2a Randomized, Open-label Study to Assess the Safety, Tolerability, and Efficacy of BAX69 in Combination with 5-FU/Leucovorin or Panitumumab versus Standard of Care in Subjects with Metastatic... 2017-02-18 due-trials
Listed as ongoing, but also has a completion date and reported results 2015-001751-76 A Phase 3 Randomized, Double-blind, Multicenter Study to Evaluate Efficacy, Safety, and Immunogenicity of an Adalimumab Biosimilar (M923) and Humira® in Subjects with Moderate to Severe Chronic Plaque... 2017-04-04 bad-data
Other 2015-002136-40 Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) < 6 years... not-yet-due
Completed, but no date Terminated 2015-002345-64 A Phase 2 Study to Assess the Efficacy and Safety of Intravenous Infusion with Human Soluble Recombinant Fc-gamma Receptor IIB (SM101/BAX 1810) in Subjects with Immunoglobulin A Nephropathy (IgAN) bad-data
Exempt, with results Terminated 2015-003492-29 A Phase 1/2a, Open-Label, Parallel, Two-Arm, Dose-Escalation not-yet-due
Other 2015-005521-39 A Phase 3, Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects with Congenital Hemophilia A with Factor VIII ... not-yet-due
Ongoing 2015-005781-39 A Phase 3b/4, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Patie... not-yet-due
Ongoing 2016-000374-37 Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuro... not-yet-due
Ongoing 2016-001477-33 A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding... not-yet-due
Ongoing 2016-001478-14 A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONAL not-yet-due
Other 2016-003438-26 Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases not-yet-due
Other 2017-000573-37 A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) not-yet-due
Other 2017-000858-18 A phase 3, prospective, randomized, controlled, open-label, multicenter, 2-period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophy... not-yet-due
Ongoing 2018-003453-16 A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD) not-yet-due
Ongoing 2018-003775-35 A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy o... not-yet-due
Exempt 2018-004024-11 An Open-Label, Multinational, Phase 1/2 Study of the Safety and Dose Escalation of SHP648, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing FIX Padua in Hemophilia B Subjects not-yet-due

Related organisations

Over time organisations can merge, or split.

We think Baxalta Innovations GmbH is now effectively part of Takeda.