Treatment of Congenital Factor VII Deficiency (F7CONDEF)

Novo Nordisk

Status: Completed

Conditions: Congenital Bleeding Disorder; Congenital FVII Deficiency

Treatments: Drug: Plasma-derived FVII (LFB); Drug: Plasma-derived FVII conc. (pdFVII Baxter); Drug: Prothrombin Complex conc. (PCC); Drug: Fresh frozen plasma (Source unspecified); Drug: Plasma-derived FVII conc. (pdFVII PFL); Drug: activated recombinant human factor VII

Study type: Observational

Funder types: Industry

Identifiers

NCT01779921

F7HAEM-3578

Details and patient eligibility

About

This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.

Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.

Enrollment: 163 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Signed informed consent by the patient or next of kin or legally acceptable representative to collect data on treatment of a given bleeding episode, surgical event or prophylactic regimen as specified in the protocol. If informed consent is provided by the next of kin or legally acceptable representative, consent must also be obtained from the patient as soon as he/she is able to do so. Informed consent should preferentially be obtained before initiation of treatment or as a minimum before entry of data into the database
• Any patient with a FVII deficiency for whom treatment of bleeding episodes, prevention related to surgery and primary/secondary prophylaxis is considered necessary by the treating physician can be enrolled
• Patients with FVII deficiency without any immediate need for treatment will be entered as stand by registered patients with capture of baseline- and demographic data only. Admission data is entered once an event occurs

Trial design

163 participants in 1 patient group

FVII

Treatment:

Drug: Fresh frozen plasma (Source unspecified)

Drug: Prothrombin Complex conc. (PCC)

Drug: Plasma-derived FVII (LFB)

Drug: Plasma-derived FVII conc. (pdFVII Baxter)

Drug: Plasma-derived FVII conc. (pdFVII PFL)

Drug: activated recombinant human factor VII