Haemophilia A Clinical Trial
— explorer™6Official 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)
| Verified date | November 2021 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
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,
| 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 |
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