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Coagulation Factor

SEVENFACT® for Hemophilia

Phase 4

Recruiting

Led By Mark Reding, MD

Research Sponsored by American Thrombosis and Hemostasis Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of hemophilia A or B with inhibitors

Be 12 years of age and older

Must not have

Have an elective surgical procedure planned during the duration of their participation in the study

Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of consent through be onset until 3 days after last dose of sevenfact®.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing a new medication for people with Hemophilia A or B with inhibitors. The trial is open-label, which means that everyone will receive the study drug. The trial will enroll participants in the United States who are 12 years of age or older.

Who is the study for?

This trial is for individuals aged 12 and older with Hemophilia A or B who have inhibitors. Participants must understand the study, be able to use an app or diary for tracking bleeding events and medication usage, and not have other clotting disorders or conditions that could interfere with the study.

What is being tested?

The trial is testing SEVENFACT®, a coagulation factor VIIa [recombinant]-jncw, in people with Hemophilia A or B experiencing breakthrough bleeding events. It's open-label and includes those on prophylactic treatment like emicizumab as well as those without it.

What are the potential side effects?

Potential side effects of SEVENFACT® may include allergic reactions (especially if sensitive to rabbit proteins), blood clots, and general discomfort at the injection site. The full range of side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have hemophilia A or B with inhibitors.

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I am 12 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a planned surgery during the study period.

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I am taking unapproved medication to prevent bleeding.

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I have a bleeding disorder in addition to Hemophilia A or B.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of consent through be onset until 3 days after last dose of sevenfact®.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of consent through be onset until 3 days after last dose of sevenfact®.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of consent through be onset until 3 days after last dose of sevenfact®. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants and percentage of Safety Events (AEs)

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.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hemophilia A and B CasesExperimental Treatment1 Intervention

SEVENFACT® has been approved for the treatment of bleeding events in individuals with hemophilia A or B with inhibitors. This study is intended to further investigate the safety and tolerability of SEVENFACT in participants with hemophilia A or B with inhibitors in the presence or absence of prophylactic therapies. Dosing will be at the discretion of the attending physician, and each participant will be supplied with the equivalent of nine 75 µg/kg doses, which aligns with the recommended dosing schedule as provided in SEVENFACT's United States Prescribing Information (USPI). In the event of a bleeding episode (BE), the participant will either self-administer the correct dose under the guidance of the treating investigator or the dose will be administered at a treatment facility.

0 / 5Eligibility criteria met