Study of recombinant factor VIIa fusion protein (rVIIa-FP, CSL689) for ondemand treatment of bleeding episodes in patients with hemophilia A or B with inhibitors

Phase 1

Active, not recruiting

• Conditions: Hemophilia A or B; MedDRA version: 20.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000004850; MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-001309-26-IT
• Lead Sponsor: CSL BEHRING GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-03-28
• Study Start: 2021-01-21
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

1. Male subjects with hemophilia A or B and inhibitors.
2. Age =12 and =65 years.
3. High responding inhibitor with documented historical inhibitor titer >5 Bethesda Units (BU)/mL.
4. Body weight =100 kg.
5. Written informed consent for study participation obtained from the subject or the subject’s legally acceptable representative (as appropriate) before undergoing any study-specific procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 53
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Congenital or acquired coagulation disorders other than hemophilia A or B.
2. Ongoing immune tolerance induction therapy or planned immune tolerance induction therapy during the study period until the last follow-up visit.
3. Known or suspected hypersensitivity to any excipient of CSL689.
4. Known or clinically suspected allergy to activated recombinant human FVII.
5. Known active pseudotumors.
6. Body mass index >30 kg/m².
7. Platelet count <50,000 platelets/µL.
8. Major surgery within 28 days before screening (catheter, stents, dental procedures, and port insertion are acceptable).
9. Scheduled major and / or orthopedic surgery during the study period through follow-up visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified