A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)

Haemophilia A Clinical Trial

— explorer™6  

Official title:

A Prospective, Multi-national, Non-interventional Study in Haemophilia A and B Patients With or Without Inhibitors Treated According to Routine Clinical Treatment Practice (Explorer™6)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741881
• Other study ID #: NN7415-4322
• Secondary ID: U1111-1182-3359
• Status: Completed
• Start date: December 18, 2018
• Est. completion date: October 25, 2021

Study information

• Verified date: November 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.

2. Male, age equal to or above 12 years at the time of signing informed consent.

3. Patients with congenital haemophilia with inhibitors treated with FEIBA® prophylaxis:

equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1). (For Turkey only: Patients with congenital haemophilia with inhibitors treated with by-passing agents prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1)).

4. Severe (FVIII activity below 1%) congenital haemophilia A or severe/moderate (FIX activity equal to or below 2%) congenital haemophilia B, or congenital haemophilia A or B of any severity, with a presence or history of inhibitor (equal to or above 0.6 Bethesda Unit (BU)), based on medical records

5. Patients with CHwI treated on-demand: equal to or above 6 treated (with bypassing agent) bleeding episodes within 24 weeks (or equal to or above 12 during 52 weeks) before screening (visit 1) and patients with severe congenital HA/HB treated on-demand: equal to or above 5 treated (with factor product) bleeding episodes within 24 weeks (or equal to or above 10 during 52 weeks) before screening (visit 1).

Exclusion Criteria:

1. Known or suspected hypersensitivity to monoclonal antibodies.

2. Previous participation in this study. Participation is defined as signed informed consent.

3. Any disorder, except for conditions associated with congenital haemophilia, which in the physician's opinion might jeopardise patient's safety or compliance with the protocol.

4. Previous treatment with concizumab. Previous treatment is defined as two or more doses administered.

5. Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.

6. Current or planned treatment with emicizumab.

7. Any known congenital or acquired coagulation disorder other than congenital haemophilia.

8. History of thromboembolic disease, current clinical signs of or treatment for thromboembolic disease, or at high risk of thromboembolic disease as judged by the investigator.

9. Presence or history of malignant neoplasm within 5 years prior to the day of screening.

Related Conditions & MeSH terms

• Haemophilia A
• Haemophilia A With Inhibitors
• Haemophilia B
• Haemophilia B With Inhibitors
• Hemophilia A
• Hemophilia B

Intervention

Other:
• No treatment given
Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).

Locations

Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Algiers
Algeria	Novo Nordisk Investigational Site	Constantine
Australia	Novo Nordisk Investigational Site	Melbourne	Victoria
Australia	Novo Nordisk Investigational Site	Murdoch	Western Australia
Australia	Novo Nordisk Investigational Site	Parkville	Victoria
Austria	Novo Nordisk Investigational Site	Amstetten
Bosnia and Herzegovina	Novo Nordisk Investigational Site	Banja Luka
Bulgaria	Novo Nordisk Investigational Site	Plovdiv
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Varna
Canada	Novo Nordisk Investigational Site	Calgary	Alberta
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	Saint John	New Brunswick
Canada	Novo Nordisk Investigational Site	St. John's	Newfoundland and Labrador
Croatia	Novo Nordisk Investigational Site	Zagreb
Croatia	Novo Nordisk Investigational Site	Zagreb
Estonia	Novo Nordisk Investigational Site	Tallinn
Finland	Novo Nordisk Investigational Site	Helsinki
France	Novo Nordisk Investigational Site	Brest
France	Novo Nordisk Investigational Site	Bron Cedex
France	Novo Nordisk Investigational Site	Caen
France	Novo Nordisk Investigational Site	Kremlin-Bicêtre
France	Novo Nordisk Investigational Site	Lille
France	Novo Nordisk Investigational Site	Nantes Cedex 1
France	Novo Nordisk Investigational Site	Paris
France	Novo Nordisk Investigational Site	Rennes
France	Novo Nordisk Investigational Site	Saint Etienne
Germany	Novo Nordisk Investigational Site	Bonn
Germany	Novo Nordisk Investigational Site	Homburg
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Thessaloniki
Hungary	Novo Nordisk Investigational Site	Budapest
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Kolkatta	West Bengal
India	Novo Nordisk Investigational Site	New Dehli	New Delhi
India	Novo Nordisk Investigational Site	Pune	Maharashtra
India	Novo Nordisk Investigational Site	Vellore	Tamil Nadu
Israel	Novo Nordisk Investigational Site	Tel-Hashomer
Italy	Novo Nordisk Investigational Site	Castelfranco Veneto
Italy	Novo Nordisk Investigational Site	Firenze
Italy	Novo Nordisk Investigational Site	Roma
Italy	Novo Nordisk Investigational Site	Udine
Italy	Novo Nordisk Investigational Site	Verona
Japan	Novo Nordisk Investigational Site	Aichi
Japan	Novo Nordisk Investigational Site	Hiroshima
Japan	Novo Nordisk Investigational Site	Hyogo
Japan	Novo Nordisk Investigational Site	Kagoshima
Japan	Novo Nordisk Investigational Site	Kanagawa
Japan	Novo Nordisk Investigational Site	Kyoto
Japan	Novo Nordisk Investigational Site	Mie
Japan	Novo Nordisk Investigational Site	Nara
Japan	Novo Nordisk Investigational Site	Niigata
Japan	Novo Nordisk Investigational Site	Osaka
Japan	Novo Nordisk Investigational Site	Saitama
Japan	Novo Nordisk Investigational Site	Saitama
Japan	Novo Nordisk Investigational Site	Shizuoka
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Jeju-do
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Lithuania	Novo Nordisk Investigational Site	Vilnius
Lithuania	Novo Nordisk Investigational Site	Vilnius
Malaysia	Novo Nordisk Investigational Site	Selangor Darul Ehsan
Mexico	Novo Nordisk Investigational Site	Monterrey	Nuevo León
Netherlands	Novo Nordisk Investigational Site	Groningen
Norway	Novo Nordisk Investigational Site	Oslo
Poland	Novo Nordisk Investigational Site	Krakow
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Warszawa
Portugal	Novo Nordisk Investigational Site	Porto
Russian Federation	Novo Nordisk Investigational Site	Krasnodar
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Serbia	Novo Nordisk Investigational Site	Belgrade
Serbia	Novo Nordisk Investigational Site	Belgrade
Serbia	Novo Nordisk Investigational Site	Kragujevac
Serbia	Novo Nordisk Investigational Site	Novi Sad
Slovakia	Novo Nordisk Investigational Site	Bratislava
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Parktown, Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Polokwane	Limpopo
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Málaga
Spain	Novo Nordisk Investigational Site	Oviedo
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Valencia
Sweden	Novo Nordisk Investigational Site	Malmö
Sweden	Novo Nordisk Investigational Site	Solna
Switzerland	Novo Nordisk Investigational Site	Zürich
Turkey	Novo Nordisk Investigational Site	Adana
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Antalya
Turkey	Novo Nordisk Investigational Site	Bornova-IZMIR
Turkey	Novo Nordisk Investigational Site	Capa-ISTANBUL
Turkey	Novo Nordisk Investigational Site	Edirne
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Samsun
Ukraine	Novo Nordisk Investigational Site	Kyiv
Ukraine	Novo Nordisk Investigational Site	Lviv
United Kingdom	Novo Nordisk Investigational Site	Belfast
United Kingdom	Novo Nordisk Investigational Site	Birmingham
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Manchester
United Kingdom	Novo Nordisk Investigational Site	Nottingham
United Kingdom	Novo Nordisk Investigational Site	Sheffield
United States	Novo Nordisk Investigational Site	Albuquerque	New Mexico
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Augusta	Georgia
United States	Novo Nordisk Investigational Site	Aurora	Colorado
United States	Novo Nordisk Investigational Site	Charleston	South Carolina
United States	Novo Nordisk Investigational Site	Charlotte	North Carolina
United States	Novo Nordisk Investigational Site	Charlotte	North Carolina
United States	Novo Nordisk Investigational Site	Charlottesville	Virginia
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Cleveland	Ohio
United States	Novo Nordisk Investigational Site	Dayton	Ohio
United States	Novo Nordisk Investigational Site	Detroit	Michigan
United States	Novo Nordisk Investigational Site	East Lansing	Michigan
United States	Novo Nordisk Investigational Site	Hershey	Pennsylvania
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Macon	Georgia
United States	Novo Nordisk Investigational Site	Milwaukee	Wisconsin
United States	Novo Nordisk Investigational Site	Nashville	Tennessee
United States	Novo Nordisk Investigational Site	Newark	New Jersey
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Sacramento	California
United States	Novo Nordisk Investigational Site	Saint Louis	Missouri
United States	Novo Nordisk Investigational Site	Salt Lake City	Utah
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Australia,  Austria,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of treated bleeding episodes	Count of treated bleeding episodes	From enrolment (week 0) and up to a maximum of 115 weeks
Secondary	The number of all bleeding episodes	Count of bleeding episodes	From enrolment (week 0) and up to a maximum of 115 weeks