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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

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

Study 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.Check my eligibility

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.See study design

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

Select...

I have hemophilia A or B with inhibitors.

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I am 12 years old or older.

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

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

Primary outcome measures

Number of participants and percentage of Safety Events (AEs)

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

LFB USA, Inc.Industry Sponsor

2 Previous Clinical Trials

37 Total Patients Enrolled

2 Trials studying Hemophilia A

37 Patients Enrolled for Hemophilia A

American Thrombosis and Hemostasis NetworkLead Sponsor

9 Previous Clinical Trials

4,438 Total Patients Enrolled

7 Trials studying Hemophilia A

4,287 Patients Enrolled for Hemophilia A

Mark Reding, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

coagulation factor VIIa [recombinant]-jncw (Coagulation Factor) Clinical Trial Eligibility Overview. Trial Name: NCT04647227 — Phase 4

Hemophilia A Research Study Groups: Hemophilia A and B Cases

Hemophilia A Clinical Trial 2023: coagulation factor VIIa [recombinant]-jncw Highlights & Side Effects. Trial Name: NCT04647227 — Phase 4

coagulation factor VIIa [recombinant]-jncw (Coagulation Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04647227 — Phase 4

Frequently Asked Questions

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

What are the typical indications for this type of treatment?

"This therapeutic intervention is frequently used to address surgical procedures, as well as other issues like fVIII inhibitors and hemorrhaging."

Answered by AI

What is the upper limit of participants in this experiment?

"The clinical trial requires the enrollment of 55 eligible volunteers. These individuals can become part of this research project at either the Center for Bleeding and Clotting Disorders in Minneapolis, Minnesota or M Health's Centre for Inherited Blood Diseases located in Orange, California."

Answered by AI

Does this experiment offer me the opportunity to participate?

"This medical trial seeks to recruit 55 individuals with hemophilia b between the ages of 12 and 100. To qualify, they must be able to demonstrate their prior history of inhibitor levels, use either a mobile application or paper diary for documentation purposes, have been diagnosed with hemophilia A or B along with inhibitors present in their system, and sign off on written informed consent/assent documents that outline the conditions of the protocol."

Answered by AI

Is enrollment currently open for this trial?

"Affirmative. Records on clinicaltrials.gov verify that this trial, which was published initially on June 28th 2021, is currently recruiting participants. 55 people need to be enrolled from 26 distinct locations."

Answered by AI

Is there a wide distribution of hospitals participating in the research within this state?

"Participating sites include the Center for Bleeding and Clotting Disorders, M Health in Minneapolis, Center for Inherited Blood Disorders in Orange, Children's National Hemophilia Centre in Washington DC, as well as an additional 23 other medical centres."

Answered by AI

Has this therapeutic approach received FDA endorsement?

"This treatment has been approved and is thus given a safety rating of 3, according to our team at Power. This indicates that it is in Phase 4 clinical trials."

Answered by AI

Has this trial been conducted previously or is it a pioneering endeavor?

"This specific treatment has been subject to research since 2020, when Janssen Research & Development, LLC first conducted a trial with 46 participants. Subsequently granted Phase 1 drug approval, there are currently 4 active trials for this medication occurring in 42 cities and 8 nations."

Answered by AI

Are there any other research initiatives that have investigated this treatment's efficacy?

"Currently, there are 4 trials in progress for this specific medication with 2 of them currently at Phase 3. These studies are conducted in 74 different medical facilities primarily situated in Atlanta, GA."

Answered by AI

Is this research study including geriatric participants?

"According to the study parameters on this trial, participants between 12 and 100 years of age are eligible. 94 studies involving those under 18 y/o have been done while 357 involve seniors over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

2021. "SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04647227.

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