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Coagulation Factor
Recombinant Factor VIIa for Hemophilia (SCOPE HIM Trial)
Phase 3
Recruiting
Led By Miguel ESCOBAR, MD
Research Sponsored by Laboratoire français de Fractionnement et de Biotechnologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 hours after surgical wound closure
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial looks at the safety & effectiveness of treating hemophilia A & B in teens & adults before surgery.
Who is the study for?
This trial is for males aged 12-65 with congenital hemophilia A or B who have inhibitors to factor VIII or IX and are scheduled for elective major surgery. They must not have other coagulation disorders, be immunosuppressed, allergic to rabbit proteins, on certain medications like emicizumab outside of specific parameters, or have had recent thromboembolic events.
What is being tested?
The study tests the safety and effectiveness of Coagulation Factor VIIa (Recombinant) in preventing excessive bleeding during major surgeries in patients with hemophilia A or B with inhibitors. It's an international Phase 3 trial where all participants receive the same treatment.
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of blood clots leading to stroke or heart attack, and possible allergic reactions if sensitive to rabbit proteins included in the medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at wound closure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at wound closure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
proportion of successfully at 120 hours after surgery
proportion of successfully at 24 hours after surgery
proportion of successfully at wound closure
Side effects data
From 2015 Phase 3 trial • 27 Patients • NCT020203698%
Headache
4%
subarachnoid hemorrhage
4%
acute tonsillitis
4%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Coagulation Factor VIIa (Recombinant): 75 µg/kg
Coagulation Factor VIIa (Recombinant): 225 µg/kg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Coagulation Factor VIIa (Recombinant)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coagulation Factor VIIa (Recombinant)
2016
Completed Phase 3
~40
Find a Location
Who is running the clinical trial?
Laboratoire français de Fractionnement et de BiotechnologiesLead Sponsor
27 Previous Clinical Trials
4,002 Total Patients Enrolled
Miguel ESCOBAR, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking emicizumab following the prescribed dosing.I haven't taken any experimental drugs recently.I have a positive inhibitor test or am expected to not respond well to certain clotting factor treatments.I am currently undergoing immune tolerance therapy.I have not had blood clots in the last 2 years.I have an active cancer other than non-melanoma skin cancer.I am taking medication that affects blood clotting.I have a blood clotting disorder that is not hemophilia A or B.I have taken blood clot prevention medication recently.I am scheduled for multiple major surgeries at once.I am a male diagnosed with hemophilia A or B, regardless of severity.I am scheduled for a major surgery as outlined in the study.I understand and agree to follow the study's requirements.I have liver or kidney problems that affect my daily life.I do not have any severe illnesses that could affect my participation in the study.I have not taken any FVII or FVIIa products in the last 24 hours.I cannot take certain blood clot prevention medications.I have an active stomach or upper small intestine ulcer.I am between 12 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Coagulation Factor VIIa (Recombinant)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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