A Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia
NCT03481946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2020-09-16
Summary
The primary objective of this study is to assess the pharmacokinetics in patients with severe hemophilia.
The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue factor pathway inhibitor activity
Conditions
- Hemophilia A; Hemophilia B
Interventions
- DRUG
-
BAY1093884
0.3 mg/kg given intravenously
- DRUG
-
BAY1093884
1 mg/kg given intravenously
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-10
- Primary Completion
- 2018-10-17
- Completion
- 2019-02-20
- FDA Drug
- Yes
Countries
- Israel
Study Locations
More Related Trials
-
Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors
NCT01921855 ·Status: COMPLETED ·Phase: PHASE1
-
Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
NCT02483208 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980
NCT00629837 ·Status: COMPLETED ·Phase: PHASE1
-
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
NCT01653639 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150
NCT01625390 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)
NCT06349473 ·Status: RECRUITING ·Phase: PHASE1
-
BAY94-9027 PK Study Comparing to Another Long Acting Product
NCT03364998 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A
NCT01580293 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
NCT00874926 ·Status: COMPLETED
-
Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment
NCT00623480 ·Status: COMPLETED ·Phase: PHASE3
-
BAY81-8973 Pediatric Safety and Efficacy Trial
NCT01311648 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
NCT01233258 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
NCT01775618 ·Status: COMPLETED ·Phase: PHASE3
-
Prophylaxis Versus On-demand Therapy Through Economic Report
NCT01159587 ·Status: COMPLETED
-
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
NCT06579144 ·Status: RECRUITING ·Phase: PHASE1
-
Drug Use Investigation of Kovaltry in Hemophilia A Patients
NCT02941783 ·Status: COMPLETED
-
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
NCT01949792 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients
NCT01817868 ·Status: COMPLETED
-
Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies
NCT03405337 ·Status: COMPLETED
-
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
NCT05042440 ·Status: COMPLETED ·Phase: PHASE1
-
BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A
NCT00623727 ·Status: TERMINATED ·Phase: PHASE2
-
Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
NCT00621673 ·Status: TERMINATED ·Phase: PHASE4
-
Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B
NCT03995784 ·Status: COMPLETED ·Phase: PHASE2
-
Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B
NCT03307980 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
NCT00989196 ·Status: COMPLETED ·Phase: PHASE2