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Coagulation Factor

Recombinant Factor VIIa for Hemophilia (SCOPE HIM Trial)

Q: Are new participants being accepted for this experiment currently?

Clinicaltrials.gov's records reveal that this clinical trial, which was originally published on August 1st 2023, is no longer recruiting subjects at the moment. Despite not accepting new patients, there are still 99 other medical studies actively enrolling participants across multiple sites.

Q: What is the prevalence of this trial in our area?

Currently, 11 clinical trial sites are running this experiment. These locations include Atlanta, New Orleans and Minneapolis as well other cities that may be closer to you in order to reduce travel costs should you choose to partake.

Q: Is there a risk of harm from taking Coagulation Factor VIIa (Recombinant)?

Coagulation Factor VIIa (Recombinant) has previously been trialled and is considered to be a safe therapeutic intervention, thus receiving a score of 3.

Q: Does this medical research encompass individuals aged 20 and up?

The prerequisites for participation in this medical trial necessitate that the applicants must be between 12 and 65 years of age. 51 studies are available to individuals younger than 18, while there is a selection of 73 studies intended for those over the age of 65.

Phase 3

Recruiting

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

SCOPE HIM 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.Check my eligibility

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.See study design

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.

SCOPE HIM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at wound closure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at wound closure

This trial's timeline: 3 weeks for screening, Varies for treatment, and at wound closure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 • NCT02020369

Headache

subarachnoid hemorrhage

acute tonsillitis

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

Coagulation Factor VIIa (Recombinant): 75 µg/kg

Coagulation Factor VIIa (Recombinant): 225 µg/kg

SCOPE HIM 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Laboratoire français de Fractionnement et de BiotechnologiesLead Sponsor

27 Previous Clinical Trials

4,005 Total Patients Enrolled

2 Trials studying Hemophilia

32 Patients Enrolled for Hemophilia

Media Library

Coagulation Factor VIIa (Recombinant) (Coagulation Factor) Clinical Trial Eligibility Overview. Trial Name: NCT05695391 — Phase 3

Hemophilia Research Study Groups: Coagulation Factor VIIa (Recombinant)

Coagulation Factor VIIa (Recombinant) (Coagulation Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695391 — Phase 3

Hemophilia Clinical Trial 2023: Coagulation Factor VIIa (Recombinant) Highlights & Side Effects. Trial Name: NCT05695391 — Phase 3

Frequently Asked Questions

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

What criteria must be met in order to qualify for participation in this trial?

"This trial is recruiting 19 male patients aged 12 to 65 with congenital hemophilia A or B of any severity. Eligibility criteria include having a positive inhibitor test BU ≥5 (as confirmed at screening by the institutional lab) OR an inhibitor test BU <5 but expected to have an anamnestic response/refractory reaction, being capable of understanding and willing to comply with protocol conditions, Hb ≥12 g/dL, signed informed consent from patient or parent(s)/legal guardian(s), and scheduled for elective major surgery as defined in study protocol."

Answered by AI

Are new participants being accepted for this experiment currently?

"Clinicaltrials.gov's records reveal that this clinical trial, which was originally published on August 1st 2023, is no longer recruiting subjects at the moment. Despite not accepting new patients, there are still 99 other medical studies actively enrolling participants across multiple sites."

Answered by AI

What is the prevalence of this trial in our area?

"Currently, 11 clinical trial sites are running this experiment. These locations include Atlanta, New Orleans and Minneapolis as well other cities that may be closer to you in order to reduce travel costs should you choose to partake."

Answered by AI

Is there a risk of harm from taking Coagulation Factor VIIa (Recombinant)?

"Coagulation Factor VIIa (Recombinant) has previously been trialled and is considered to be a safe therapeutic intervention, thus receiving a score of 3."

Answered by AI

Does this medical research encompass individuals aged 20 and up?

"The prerequisites for participation in this medical trial necessitate that the applicants must be between 12 and 65 years of age. 51 studies are available to individuals younger than 18, while there is a selection of 73 studies intended for those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM

2024. "A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05695391.

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