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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02976753
Other study ID # Sobi.Elocta-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2016
Est. completion date November 3, 2021

Study information

Verified date February 2023
Source Swedish Orphan Biovitrum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.


Recruitment information / eligibility

Status Completed
Enrollment 361
Est. completion date November 3, 2021
Est. primary completion date November 3, 2021
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: - Male patients with a diagnosis of haemophilia A - Received prophylactic treatment with a factor product for management of haemophilia A in the 12 months prior to enrolment - At enrolment prescribed prophylactic treatment with Elocta or conventional factor product regardless of participation in the study - Having at least 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and bleeding episodes prior to the baseline visit - Signed and dated informed consent provided by the patient or the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations Exclusion Criteria: - Enrolment in a concurrent clinical interventional study involving intake of an investigational medicinal product (IMP), within 1 year prior to enrolment - Previously treated with commercially available extended half-life products other than Elocta - Presence of factor VIII inhibitors (=0.60 Bethesda Unit [BU]/mL ) at the latest available inhibitor test using the Nijmegen modified Bethesda assay

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
efmoroctocog alfa
extended half-life factor VIII product
Factor VIII
conventional factor VIII product

Locations

Country Name City State
Austria Swedish Orphan Biovitrum Research site Innsbruck
Austria Swedish Orphan Biovitrum Research site Linz
Austria Swedish Orphan Biovitrum Research Site St Polten
Austria Swedish Orphan Biovitrum Research site Vienna
Belgium Swedish Orphan Biovitrum Research site Brussel
Finland Swedish Orphan Biovitrum Research site Helsinki
France Swedish Orphan Biovitrum Research site Caen
France Swedish Orphan Biovitrum Research site Montpellier
France Swedish Orphan Biovitrum Research site Nancy
France Swedish Orphan Biovitrum Research site Rennes
Italy Swedish Orphan Biovitrum Reserach site Catanzaro
Italy Swedish Orphan Biovitrum Reserach site Florence
Italy Swedish Orphan Biovitrum Research site Milano
Italy Swedish Orphan Biovitrum Reserach site Naples
Italy Swedish Orphan Biovitrum Research Site Padova
Italy Swedish Orphan Biovitrum Reserach site Palermo
Italy Swedish Orphan Biovitrum Reserach site Parma
Italy Swedish Orphan Biovitrum Reserach site Rome
Italy Swedish Orphan Biovitrum Research site Turin
Norway Swedish Orphan Biovitrum Research site Oslo
Spain Swedish Orphan Biovitrum research site Alicante
Spain Swedish Orphan Biovitrum Reserach site Barcelona
Spain Swedish Orphan Biovitrum Reserach site Madrid
Spain Swedish Orphan Biovitrum Research site Málaga
Spain Swedish Orphan Biovitrum Reserach site Sevilla
Spain Swedish Orphan Biovitrum Research site Valencia
Sweden Swedish Orphan Biovitrum Research site Göteborg
Sweden Swedish Orphan Biovitrum Research site Malmö
Sweden Swedish Orphan Biovitrum Research site Stockholm
United Kingdom Swedish Orphan Biovitrum Research site Birmingham
United Kingdom Swedish Orphan Biovitrum Research site Canterbury
United Kingdom Swedish Orphan Biovitrum Research site Liverpool
United Kingdom Swedish Orphan Biovitrum Reserach site London
United Kingdom Swedish Orphan Biovitrum Research site Manchester
United Kingdom Swedish Orphan Biovitrum Research site Sheffield
United Kingdom Swedish Orphan Biovitrum Research site Southampton

Sponsors (2)

Lead Sponsor Collaborator
Swedish Orphan Biovitrum ICON plc

Countries where clinical trial is conducted

Austria,  Belgium,  Finland,  France,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualised bleeding rate (ABR) 24 months
Primary Annualised injection frequency 24 months
Primary Annualised factor consumption (International Unit [IU]) 24 months
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