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Factor IX + Emicizumab for Hemophilia A

Phase < 1
Recruiting
Led By Maissa Janbain, MD, MS
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of severe hemophilia A and are receiving emicizumab prophylaxis, on a weekly maintenance regimen
Male patients, Age 12 years and older at time of signing Informed Consent Form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will enroll patients with severe hemophilia A to test how different molecules (currently used and proposed as adjunctive therapy to emicizumab) affect their blood. There is minimal direct risk to patients expected.

Who is the study for?
This trial is for male patients aged 12 and older with severe hemophilia A who are already on a weekly emicizumab prophylaxis regimen. Participants must be able to sign a consent form and follow the study protocol. Those who have used any hemostatic agents recently or have other coagulopathies, or are unwilling to provide extra blood samples, cannot join.Check my eligibility
What is being tested?
The trial is testing Factor IX as an additional treatment alongside emicizumab in patients with severe hemophilia A. It's a preclinical pilot study where patient blood will be tested in the lab with different molecules to see how they work together.See study design
What are the potential side effects?
Since this is an in vitro (lab-based) study using patients' blood samples, there's minimal direct risk involved. Therefore, no significant side effects from interventions are expected for participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe hemophilia A and am on a weekly emicizumab treatment.
Select...
I am a male aged 12 or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the hemostatic effect of Factor IX concentrates and recombinant porcine FVIII when added to the plasma of patients with Hemophilia A with inhibitors on emicizumab using Endogenous Thrombin Potential (ETP)
Determine the hemostatic effect of Factor IX concentrates and recombinant porcine FVIII when added to the plasma of patients with Hemophilia A with inhibitors on emicizumab using peak thrombin
Determine the homeostatic effect of adding Factor IX concentrate to the plasma of patients with Hemophilia A with inhibitors on emicizumab using Endogenous Thrombin Potential (ETP)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patient GroupExperimental Treatment1 Intervention
In vitro spiking experiments will be realized in plasmas from patients with severe haemophilia A on emicizumab using increasing concentrations of factor IX (rFIX), Activated prothrombin complex (aPCC) and recombinant VIIa (rFVIIa).

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,462 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,859 Total Patients Enrolled
16 Trials studying Hemophilia A
3,820 Patients Enrolled for Hemophilia A
Maissa Janbain, MD, MSPrincipal InvestigatorTulane University

Media Library

Factor IX Clinical Trial Eligibility Overview. Trial Name: NCT05281718 — Phase < 1
Hemophilia A Research Study Groups: Patient Group
Hemophilia A Clinical Trial 2023: Factor IX Highlights & Side Effects. Trial Name: NCT05281718 — Phase < 1
Factor IX 2023 Treatment Timeline for Medical Study. Trial Name: NCT05281718 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there the possibility of me participating in this experiment?

"This research trial is accepting 40 individuals with hemophilia A to participate in the study. Applicants should have an age range between 12 and 120 years old."

Answered by AI

Are there any openings remaining in this research program?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical investigation, first announced on August 1st 2022, is currently gathering participants. Approximately 40 volunteers must be recruited from 2 different health centres."

Answered by AI

Is this research trial recruiting adults aged 18 and above?

"According to the parameters of this clinical trial, individuals aged 12-120 are eligible for enrollment. Subsequently, there are 39 trials available for those under 18 and 66 options accessible to persons 65 years or older."

Answered by AI

What is the estimated size of the population taking part in this investigation?

"Affirmative, the information on clinicaltrials.gov demonstrates that this medical investigation is actively seeking enrollees. This trial was first posted in August of 2022 and has since been revised; it presently requires 40 participants from 2 centres for completion."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Factor IX as Adjunctive Therapy to Emicizumab (EMIX)
2022. "Factor IX as Adjunctive Therapy to Emicizumab (EMIX)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05281718.
All > Mens Health > Hemophilia
~3 spots leftby Jul 2024
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