SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Conditions

• Hemophilia A With Inhibitor
• Hemophilia B With Inhibitor

Eligibility Criteria

Sex

ALL

Age

12 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• coagulation factor VIIa [recombinant]-jncw — DRUG
  a transgenically produced, activated, recombinant, human factor VII (rhFVIIa) protein with the brand name of SEVENFACT®. This protein is a clotting factor in the coagulation cascade that is produced in and purified from the milk of transgenic rabbits. SEVENFACT is approved for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.

Study Details

Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.

Key Dates

Start date

Jun 28, 2021

Status verified

Jan 2026

Primary completion

Sep 30, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

55 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Hemophilia A and B Cases
  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.

Primary Outcome Measure

Number of participants and percentage of Safety Events (AEs) [ Time Frame: From time of consent through BE onset until 3 days after last dose of SEVENFACT®. ]

Central Contacts

• Carol Fedor, ND, RN, CCRC
  (800)-360-2846
  [email protected]
• Jessica Callis
  800-360-2846
  [email protected]

Locations (21)

Find similar trials in Phoenix, AZ

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