Factor IX as Adjunctive Therapy to Emicizumab (EMIX)

Status Recruiting

Clinical Trial Summary

This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients is expected. This is a pilot preclinical study.

Clinical Trial Description

The study aims to determine the hemostatic effect of different Factor IX (FIX) concentrates when added to the plasma of patients on emicizumab prophylaxis and compare it to the hemostatic effect obtained with the addition of bypassing agents (activated prothrombin complex aPCC, and recombinant VIIa rVIIA, recombinant porcine FVIII). The investigators will study the hemostatic effect using Thrombin Generation assay (CAT) in the presence of different concentrations of FIX concentrates. The investigators will compare the hemostatic effect of added FIX to the effect of added bypassing agents (activated prothrombin complex aPCC, and recombinant VIIa rVIIA, recombinant porcine FVIII) Plasma will be collected from patients with hemophilia A and inhibitors treated with Emicizumab, a group of plasma samples will be spiked with different concentrations of Factor IX. Thrombin generation profiles will be obtained using CAT. Another group of plasma samples will be spiked with different concentrations of by passing agents (activated prothrombin complex aPCC, and recombinant VIIa rVIIA, recombinant porcine FVIII). Thrombin generation profiles will be obtained using CAT. ;

Study Design

Related Conditions & MeSH terms

Hemophilia A

Clinical Trial Details

NCT number	NCT05281718
Study type	Interventional
Source	Tulane University
Contact	Maissa Janbain, MD, MS
Phone	504-988-8840
Email	mjanbain@tulane.edu
Status	Recruiting
Phase	Early Phase 1
Start date	August 1, 2022
Completion date	July 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03834727` - Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Completed	`NCT03191799` - A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors	Phase 3
Completed	`NCT01599819` - BAX 855 Dose-Escalation Safety Study	Phase 1
Terminated	`NCT04541628` - Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A	Phase 1/Phase 2
Completed	`NCT02847637` - A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors	Phase 3
Completed	`NCT04072237` - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia	Phase 1
Completed	`NCT04085458` - Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)	Phase 4
Completed	`NCT04565236` - A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A	Phase 4
Recruiting	`NCT05987449` - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A	Phase 1/Phase 2
Active, not recruiting	`NCT04621916` - Preventing Inhibitor Recurrence Indefinitely	Phase 4
Not yet recruiting	`NCT02888223` - Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A	Phase 1
Completed	`NCT02528968` - National Study of a Pharmacokinetic-Focused Educational Package for Patients With Severe Haemophilia A	N/A
Completed	`NCT02225483` - Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function	N/A
Completed	`NCT02199717` - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia	N/A
Completed	`NCT01217255` - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed	`NCT00969319` - Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America	N/A
Terminated	`NCT00995046` - Individually Tailored Prophylaxis in Patients With Severe Hemophilia A	N/A
Completed	`NCT00868530` - Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects	Phase 3
Completed	`NCT00839202` - Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay	N/A
Completed	`NCT00629837` - Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980	Phase 1