091301

About this trial

Study ID

091301

Status

Completed

Type

Observational

Phase

N/A

Placebo

Accepting

All

Male

Not accepting

Healthy Volunteers

Trial Timing

Ended 5 years ago

The study addresses the need to measure long-term effectiveness, safety and quality of life outcome measures for haemophilia A or B patients with high-responding inhibitors treated on-demand and in prophylaxis with FEIBA NF. The purpose of the study is to document the natural history of hemophilia A or B disease in subjects with high responding inhibitors either to Factor VIII or Factor IX and to describe long-term outcomes in terms of effectiveness, safety and quality of life in subjects receiving FEIBA NF in routine clinical practice.

Inclusion Criteria

Participant is a male congenital haemophilia A or B patient with high-responding inhibitor of any titer diagnosed before study entry

Participant has been prescribed treatment with Factor Eight Inhibitor Bypassing Activity Nanofiltered (FEIBA NF) as part of routine clinical practice, either on-demand, as prophylactic treatment or during immune tolerance induction (ITI)

Exclusion Criteria

Participant has a known hypersensitivity to the product or any of its components

Participant has other contraindications to FEIBA NF: FEIBA NF must not be used in the following situations if therapeutic alternatives to FEIBA NF are available:

Disseminated intravascular coagulation (DIC)

Acute thrombosis or embolism (including myocardial infarction)

Participant has any other severe concomitant clinically relevant bleeding disorder

Participant has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of this study.

Participant is a family member or employee of the investigator