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7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties
of oral rivaroxaban in children from birth to less than 6 months with arterial or venous
thrombosis

The primary objective is:- to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxabanThe secondary objectives are:- to assess the incidence of major bleeding and clinically relevant non-major bleeding- to…

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosis.

-Assess the incidence of major bleeding and clinically relevant non-major bleeding -Assess the incidence of recurrent venous thromboembolism -Characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban

A Phase II/III, multicenter, partially randomized, open label trial investigating safety and efficacy of on-demand and prophylactic treatment with BAY 94-9027 in Severe Hemophilia A

PART A: To assess the efficacy of BAY 94-9027 in prevention and treatment of bleeding at different infusion schedules.PART B: To assess the safety and efficacy of BAY 94-9027 in the prevention of bleeding during major surgical procedures.

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young children with various manifestations of venous thrombosis

- Assess the incidence of major bleeding and clinically relevant non-major bleeding- Assess the incidence of recurrent venous thromboembolism- Assess the asymptomatic deterioration in the thrombotic burden on repeat imaging- Characterize the…

Therapy of Refractory Inhibitors with immUne Modulation in Patients with Hemophilia. The TRIUMPH trial

To evaluate the efficacy, safety and feasibility of combined immune modulation with rituximab, ITI and MSCs in terms of eradication of FVIII inhibitory activity in hemophilia A patients.

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 I/II, open-label, uncontrolled, single-dose, dose-ascending, multi-centre trial investigating an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) administered to adult patients with severe or moderately severe haemophilia B

The primary objective of this study is to investigate the safety of systemic administration of AAV5-hFIX, an adeno-associated viral vector containing a codon-optimized hFIX gene, to adult patients with severe or moderately severe haemophilia B.…