Pipeline

CLINICAL TRIALS

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HEMA Biologics

Our Ongoing Commitment to the Hemophilia Community

Part of our ongoing commitment to helping people with rare bleeding disorders—we have pursued additional trials with Eptacog Beta with the goal of gaining approval for future treatment indications.

Our Clinical Trials

Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients

Official Title: 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 (SCOPE HIM)

Condition/disease: Hemophilia A or B with inhibitors

Study Phase: Phase 3

Brief Summary: This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII) or factor IX (FIX) undergoing elective major surgical procedures.

Interventions: Drug: LR769

NCT Number: 05695391

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U.S. Locations:

These are the locations in the US participating in the SCOPE HIM clinical trial. Contact information is available for each US location at www.clinicaltrials.gov.

  • Los Angeles, California
  • Atlanta, Georgia
  • New Orleans, Lousiana
  • Minneapolis, Minnesota
  • Houston, Texas

Patient Eligibility Criteria
Age Range: 12 to 65 years
Gender: Male
Hemophilia A or B with inhibitors
Upcoming elective Major Surgical Procedure

Status: In Recruitment phase

First posted: 6/7/2024

Previously Held Clinical Trials

A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B (rhFVIIa)

Official Title: A Phase 1b, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With or Without Inhibitors

Condition/disease: Hemophilia

Study Phase: Phase Ib

Brief Summary: This study will assess the safety, pharmacokinetics, and pharmacodynamics of rhFVIIa at three dose levels (25, 75, and 225 mcg/kg). The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with rhFVIIa.

Interventions: Drug: rhFVIIa

NCT Number: NCT01708564

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Locations:
Netherlands
United States

Age Range: 18 to 75 years

Status: Completed

First posted: October 17, 2012

Last update: July 30, 2013

Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors (PERSEPT 1)

PERSEPT = Program for the Evaluation of Recombinant factor Seven Efficacy by Prospective clinical Trials

Official Title: A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX

Condition/disease: Hemophilia A or B

Study Phase: Phase III

Brief Summary: The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX.

Interventions: Drug: Coagulation Factor VIIa (Recombinant), Crossover Assignment

NCT Number: NCT02020369

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Locations:
Belarus
Bulgaria
Georgia
Israel
Poland
Romania
Russian Federation
Ukraine
United Kingdom
United States

Age Range: 12 to 75 years

Status: Completed

First posted: December 24, 2013

Last update: June 14, 2017

A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (PERSEPT 2)

Official Title: A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients From Birth to <12 Years Old With Inhibitors to Factor VIII or IX: PerSept 2

Condition/disease: Hemophilia A or B

Study Phase: Phase III

Brief Summary: The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients (birth to <6 years old), and 12 patients (≥6 years old to <12 years old).

Interventions: Drug: Coagulation Factor VIIa (Recombinant), Crossover Assignment

NCT Number: NCT02448680

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Locations:
Bulgaria
Czechia
Georgia
South Africa Ukraine
United States

Age Range: up to 11 years

Status: Completed

First posted: August 28, 2020

Last update: September 29, 2020

Eptacog Beta in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures (PERSEPT 3)

Official Title: Phase 3 Study of Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for Prevention of Excessive Bleeding in Congenital Hemophilia A/B Patients With Inhibitors to Factor VIII/IX Undergoing Elective Surgery/Other Invasive Procedures

Condition/disease: Hemophilia A or B

Study Phase: Phase III

Brief Summary: The purpose of this study, PERSEPT 3, is to evaluate eptacog beta for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who are undergoing elective surgical or other invasive procedures. Administration of eptacog beta will be performed just prior to surgery/procedure and will be repeated during and after the surgery/procedure to achieve and maintain adequate hemostasis as determined by the investigator's judgment.

Interventions: Drug: Coagulation Factor VIIa (Recombinant), Single Group Assessment

NCT Number: NCT02448680NCT02548143

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Locations:
Mexico
Russian
Federation
South Africa
Spain
Ukraine
United States

Age Range: 6 months to 75 years

Status: Completed

First posted: September 6, 2019

Last update: May 14, 2020