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

Phase 1

• Conditions: Hemophilia A with inhibitors, Hemophilia B with inhibitors; MedDRA version: 18.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850; MedDRA version: 18.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-001309-26-ES
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-27
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 54

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/mL.
Are the trial subjects under 18? no
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 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Congenital or acquired coagulation disorders other than hemophilia A or B.
2. Ongoing immune tolerance induction therapy or planned during study.
3. Known or suspected hypersensitivity to activated recombinant human FVII or to any excipient of CSL689.
4. Body mass index > 30 kg/m².
5. Major surgery within 28 days before screening or scheduled major and / or orthopedic surgery during the study.
6. Advanced atherosclerotic disease (ie, known history of ischemic heart disease, or ischemic stroke).
7. Any clinical signs or known history of thromboembolic events, including known deep vein thrombosis.
8. Human immunodeficiency virus (HIV)-positive subjects who have low cluster of differentiation 4 (CD4)+ lymphocyte count (200/?L or less) at screening.
9. Use of the following within the screening period and planned during study: a) plasma or coagulation factor concentrates other than rescue therapy or therapy during the PK Module, b) other platelet inhibitors, c) desmopressin, and d) fibrinolysis inhibitors (except if used as local treatment (eg, for oral bleeds).

Study & Design

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