Clinical trials: Thrombin
Healthy
A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers
The purpose of the study is to assess the effect of multiple oral doses of canagliflozin on a single oral dose of warfarin.
- Trial name
- NCT01195324
- Testing
- Canagliflozin/Warfarin
- Where
- Belgium
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Anticoagulant Reversal, Reversal of Edoxaban Induced Anticoagulation
Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban
PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers.
- Trial name
- PER977-P1 (NCT01826266)
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Anticoagulation
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.
- Trial name
- NCT02074358
- Testing
- Apixaban, Cofact (4-Factor PCC), Beriplex P/N (4-Factor PCC)
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers
The purpose of this study is to assess the use of 2 different Prothrombin Complex Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of rivaroxaban in healthy adult volunteers.
- Trial name
- NCT01656330
- Testing
- Rivaroxaban 20 mg twice daily, Rivaroxaban 20 mg once daily, Profilnine SD
- Where
- Belgium
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact.
- Trial name
- NCT05205863
- Testing
- Cofact
- Where
- Netherlands
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Prothya Biosolutions
Chronic Disease, Endocrine System Disease
Identify Genetic Variations That Affect The Ability of Patients To Metabolize Drugs Through Metabolic Pathways
This observation will look at patient care decisions of the primary healthcare provider utilizing the results of the DNA testing of patients' metabolic pathways using 2C19, 2C9, 2D6, 3A4, Factor II, Factor V and MTHFR and VKORC1.
- Conditions
- Chronic Disease, Endocrine System Disease, Cardiovascular Disease, Respiratory Tract Disease
- Trial name
- NCT02525887
- Testing
- Observation
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Bracane Company
Healthy
A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants
The primary purpose of this study is to evaluate the reversal of the anticoagulant effects of milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) and Recombinant Human Factor VIIa (rFVIIa) in healthy participants as…
- Trial name
- NCT04543383
- Testing
- Milvexian, 4-Factor Prothrombin Complex Concentrate (4F-PCC), Recombinant Human Factor VIIa (rFVIIa)
- Where
- Netherlands
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Bleeding
A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation
This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2 treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded), randomized, placebo controlled, sequential descending…
- Trial name
- NCT02047565
- Testing
- 60mg edoxaban, 180mg edoxaban, 50 IU/kg Beriplex P/N
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Thrombosis
Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects
The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a single iv dose of E-WE Thrombin in healthy adult subjects.
- Trial name
- NCT03453060
- Testing
- E-WE Thrombin- Dose 1, E-WE Thrombin- Dose 2, E-WE Thrombin- Dose 3
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Aronora, Inc.
Healthy
A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants
The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters (bleeding duration and blood volume)…
- Trial name
- NCT02561923
- Testing
- Rivaroxaban, Tranexamic acid, Kcentra, a 4-factor PCC
- Where
- United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Janssen Scientific Affairs, LLC
Anticoagulation Reversal
Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban
This study will evaluate the establishment of anticoagulation ("re-anticoagulation") of subjects with edoxaban following reversal by PER977 and will identify a dose regimen of PER977 that reverses the effects of edoxaban for up…
- Trial name
- NCT02207257
- Testing
- PER977, Edoxaban
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Factor V Leiden, Prothrombin G20210A
A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CITY-FXI in Healthy Adults, Adults With FV Leiden or Prothrombin G20210A Mutation, and Adults With a History of Provoked Venous Thromboembolism
This is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending and multiple dose study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of…
- Conditions
- Factor V Leiden, Prothrombin G20210A, Venous Thromboembolism (VTE)
- Trial name
- NCT07430397
- Testing
- CITY-FXI
- Where
- United Kingdom
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- City Therapeutics
Thrombin Inhibition
Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.
- Trial name
- NCT01150812
- Testing
- AZD8165
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Detection and Genotyping of Factor V and Factor II Point Mutations
Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA
As an external validation test of the performance of the VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites.
- Trial name
- NCT00959504
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Illumina, Inc.
Facial Rhytidectomy (Face-lift)
Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures
The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in…
- Trial name
- NCT00708071
- Testing
- Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)
- Where
- 6 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation