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

NCT ID: NCT03741881

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-18

Study Completion Date

2021-10-25

Brief Summary

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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.

Detailed Description

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Conditions

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Haemophilia A Haemophilia A With Inhibitors Haemophilia B Haemophilia B With Inhibitors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with haemophilia

Patients with haemophilia A or B and with or without inhibitors

No treatment given

Intervention Type OTHER

Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).

Interventions

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No treatment given

Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Los Angeles, California, United States

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Sacramento, California, United States

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Aurora, Colorado, United States

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Washington D.C., District of Columbia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Macon, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Detroit, Michigan, United States

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East Lansing, Michigan, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Newark, New Jersey, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Milwaukee, Wisconsin, United States

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Algiers, , Algeria

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Constantine, , Algeria

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Murdoch, Western Australia, Australia

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Amstetten, , Austria

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Banja Luka, , Bosnia and Herzegovina

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Calgary, Alberta, Canada

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Saint John, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Zagreb, , Croatia

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Zagreb, , Croatia

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Tallinn, , Estonia

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Helsinki, , Finland

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Brest, , France

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Bron, , France

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Caen, , France

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Le Kremlin-Bicêtre, , France

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Lille, , France

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Nantes, , France

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Paris, , France

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Rennes, , France

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Saint-Etienne, , France

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Bonn, , Germany

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Homburg, , Germany

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Athens, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Bangalore, Karnataka, India

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Pune, Maharashtra, India

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New Dehli, New Delhi, India

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Vellore, Tamil Nadu, India

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Kolkata, West Bengal, India

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Tel Litwinsky, , Israel

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Castelfranco Veneto, , Italy

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Florence, , Italy

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Roma, , Italy

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Udine, , Italy

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Verona, , Italy

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Aichi, , Japan

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Hiroshima, , Japan

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Hyōgo, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kyoto, , Japan

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Mie, , Japan

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Nara, , Japan

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Niigata, , Japan

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Osaka, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Selangor Darul Ehsan, , Malaysia

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Monterrey, Nuevo León, Mexico

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Groningen, , Netherlands

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Oslo, , Norway

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Krakow, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Porto, , Portugal

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Krasnodar, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Novi Sad, , Serbia

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Bratislava, , Slovakia

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Parktown, Johannesburg, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Polokwane, Limpopo, South Africa

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Busan, , South Korea

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Daejeon, , South Korea

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Daejeon, , South Korea

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Jeju-do, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Madrid, , Spain

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Málaga, , Spain

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Oviedo, , Spain

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Seville, , Spain

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Valencia, , Spain

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Malmo, , Sweden

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Solna, , Sweden

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Zurich, , Switzerland

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Adana, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Bornova-IZMIR, , Turkey (Türkiye)

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Capa-ISTANBUL, , Turkey (Türkiye)

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Edirne, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Belfast, , United Kingdom

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Birmingham, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Nottingham, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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

References

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Wheeler AP, Abraham A, Barnes C, Brown Frandsen R, d'Oiron R, Eichler H, Hampton K, Lopez-Jaime FJ, Lyu CJ, Tavares CMM, Nogami K, Sutton C, Windyga J, Zulfikar B, Castaman G. Real-World Unmet Needs of Patients With Haemophilia A and Haemophilia B With or Without Inhibitors: End-of-Study Results From the explorer6 Non-Interventional Study. Haemophilia. 2025 Sep;31(5):903-911. doi: 10.1111/hae.70051. Epub 2025 May 5.

Reference Type DERIVED
PMID: 40323006 (View on PubMed)

Other Identifiers

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U1111-1182-3359

Identifier Type: OTHER

Identifier Source: secondary_id

NN7415-4322

Identifier Type: -

Identifier Source: org_study_id