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Current use of anticoagulants in cirrhosis: a prospective study.

Primary Objective: To assess whether the current use and dosing in cirrhosis of anticoagulation is as effective in inhibiting ex vivo thrombin generation compared to the treatment of patients with competent liver function

Effectiveness of Forced Air Preoperative warming

The primary objective of the study is to determine whether the use of pre-and intraoperative warming with a forced air technique leads to a reduction of the incidence of hypothermia compared to patients with only intra-operative forced air warming.…

A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A

This is a so-called *lead-in study* in which patients receive their standard treatment and no study treatment. The researchers will collect dataabout the patients* bleeding episodes, FVIII containing treatments used to prevent bleeding episodes and…

Desmopressin and FVIII concentrate combination treatment in non-severe hemophilia A patients undergoing minor interventions

To show a reduction in FVIII-concentrate consumption with perioperative desmopressin and FVIII concentrate combination treatment compared to FVIII concentrate monotherapy, without decreasing the effectivity of treatment.

Phase III, open-label, single-dose, multi-center multinational trial investigating a serotype 5 adeno-associated viral vector containing the Padua variant of a codon-optimized human factor IX gene (AAV5-hFIXco-Padua, AMT-061) administered to adult subjects with severe or moderately severe hemophilia B

This study has been transitioned to CTIS with ID 2024-510738-42-00 check the CTIS register for the current data. The primary aim of the trial is to demonstrate the non-inferiority of CSL222 (formerly AMT-061) (2 × 1013 gc/kg) during the 52 weeks…

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT)

This study has been transitioned to CTIS with ID 2023-510107-22-00 check the CTIS register for the current data. To assess the efficacy of ravulizumab versus placebo in the treatment of adult and adolescent participants with HSCT-TMA.

Coagubility in severe mitral regurgitation: A within-patient evaluation of coagulation status before and after Mitral Valve Transcatheter Edge-to-Edge Repair.

To evaluate coagulation status in patients with moderate-severe to severe MR, with concomitant atrial enlargement or atrial fibrillation, before and after M-TEER to explore the complex relationship between MR and coagulability.

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II

This study has been transitioned to CTIS with ID 2023-505904-41-00 check the CTIS register for the current data. Primary Objective: To assess the safety of long-term administration of KVD900 in adolescent and adult patients with HAE type I or II.…

Tranexamic acid during excisional burn surgery

This study has been transitioned to CTIS with ID 2024-513573-49-00 check the CTIS register for the current data. The objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces the volume of blood loss and number of…

A phase 1/2 open-label safety and dose-finding study of BAY 2599023 (DTX201), an adeno-associated virus (AAV) hu37-mediated gene transfer of B-domain deleted human factor VIII, in adults with severe hemophilia A

This study has been transitioned to CTIS with ID 2023-505827-29-00 check the CTIS register for the current data. The purpose of this first in human study is to determine if the gene transfer study product, BAY 2599023 (DTX201), is safe and has…

Safety and efficacy of nadroparin in neonates: an observational study.

Therapeutic nadroparin administration:Primary objective: To develop evidence-based dosing regimens of nadroparin for extremely premature, premature and term neonates by means of the objectification of the PK/PD of nadroparin.Secondary objective: 1)…

Heavy menstrual bleeding in premenopausal women treated with direct oral anticoagulants - a randomised controlled trial.

To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy.

A Phase I/IIb extension study assessing the long-term safety and efficacy of an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) previously administered to adult patients with severe or moderately severe haemophilia B during the CT-AMT-060-01 Phase I/II study.

This study has been transitioned to CTIS with ID 2024-512603-39-00 check the CTIS register for the current data. Primary: To assess the long-term safety (6-10 years after dosing) of a systemic administration of AAV5-hFIX, an AAV vector containing a…

A multicenter, Phase 2a, open-label, non-randomized study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with persistent/chronic immune thrombocytopenia (ITP)

To evaluate the effect of BIVV020 on the durabilityof platelet response in participants withpersistent/chronic immune thrombocytopenia (ITP)Secondary• To assess the safety and tolerability of BIVV020• To assess the pharmacokinetics (PK) of BIVV020•…

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger

PrimaryTo assess the efficacy of ravulizumab in the treatment of participants with TMASecondaryTo characterize TMA responseTo assess impact on hemoglobin levels To evaluate change in kidney function To assess duration of Complete TMA Response and…

An Open-Label Study to Assess the Effects of VMX-C001 in Combination with an Oral FXa DOAC on the Efficacy of Unfractionated Heparin in Healthy Subjects.

This study has been transitioned to CTIS with ID 2024-514339-87-00 check the CTIS register for the current data. Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.…

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered Prothrombin Complex Concentrate (PCC) in Combination with a Selected FXa Direct Oral Anticoagulant (FXa DOAC) in Healthy Subjects.

Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…

A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors.

Primary objectives:- To confirm the haemostatic effect of Mim8 as treatment prophylaxis for adult and adolescent patients with haemophilia A with or without inhibitors.Secondary objectives:- To investigate safety of Mim8 prophylaxis in adults and…

Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors

Primary objective: To investigate the safety of Mim8 prophylaxis in children with haemophilia A with or without FVIII inhibitors.Secondary objectives• To investigate the efficacy of Mim8 prophylaxis in children with haemophilia A with or without…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary
Angioedema Type I or I

Primary Objective: To demonstrate the clinical efficacy of KVD900 compared with placebo for the on-demand treatment of HAE attacks.Secondary Objective: To investigate the safety and tolerability of KVD900.