NCT02018393

Case-control Pilot Study of the Immune Modulating Effect of FEIBA on Patients With Haemophilia A and Inhibitors

Case-control Pilot Study of the Immune Modulating Effect of FEIBA on Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the immunomodulatory effect of FEIBA® in patients with severe haemophilia A and inhibitors.

Detailed description

This is an observational, multicentric, case-control and one-single-visit study of patients with severe haemophilia A and inhibitors against FVIII in therapy with FEIBA®. Two subject groups will be included: Group 1 (cases) will be composed of patients with severe haemophilia A and inhibitors in prophylaxis with FEIBA®; Group 2 (controls) will be composed of patients with severe haemophilia A and inhibitors on-demand treatment with FEIBA®.

Conditions

• Severe Haemophilia A With Inhibitors

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2013-12-23
• Last updated: 2013-12-23

Locations

1 site across 1 country: Spain