Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese...
Congenital Bleeding DisorderHaemophilia A2 moreThis trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered subcutaneously, at two different dose levels, in healthy Japanese subjects.
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
Severe Hemophilia AThe primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing...
Haemophilia AThe main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.
Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A...
Hemophilia AHemophilia BThis is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with moderate or severe congenital hemophilia A or B with or without inhibitors. This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses to be examined in subsequent studies.
A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor...
Haemophilia BThe purpose of this study is: to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg. to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches. to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation...
Hemophilia BThis study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
Congenital Bleeding DisorderHaemophilia A2 moreThis trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B
Study of Biostate® in Children With Hemophilia A
Hemophilia AThe objective of this study is to assess the efficacy and safety of a Von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, and to investigate the pharmacokinetics of Biostate in children with haemophilia A.
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII...
Hemophilia AThe primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.
Efficacy and Safety of IL-11 in DDAVP Unresponsive
Hemophilia AVon Willebrand DiseaseThe purpose of this study is to determine the biologic efficacy and safety of rhIL-11 when given subcutaneously in adults with moderate or mild hemophilia A or Von Willebrand disease unresponsive to DDAVP. Biologic efficacy will be measured by the number and percent increase of VWD coagulation tests (FVIII:C, VWF: Ag, VWF: RCo, closure time, APTT, and VWF multimers) to the normal range, or at least to 1.5-3 time baseline, following dosing of rhIL-11 when given daily for 4 days, and boosted by DDAVP infusion on day 4, in those in whom DDAVP is not contraindicated. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.