A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/6/2019 |
| Start Date: | December 18, 2018 |
| End Date: | July 20, 2020 |
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)
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 1½
years.
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 1½
years.
Inclusion Criteria:
- 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.
- Male, age greater than or equal to 12 years at the time of signing informed consent.
- Severe (FVIII [factor 8] activity less than 1%) congenital haemophilia A or severe
(FIX [factor 9] activity less than 1%) congenital haemophilia B or congenital
haemophilia A or B with inhibitors, based on medical records at the full discretion of
the treating physician.
- Patients with congenital haemophilia A or B with inhibitors (CHwI) treated on-demand:
greater than or equal to 6 treated (with bypassing agent) bleeding episodes within 24
weeks before screening (visit 1) and patients with severe congenital haemophilia A
(HA)/ haemophilia B (HB) treated on-demand: greater than or equal to 5 treated (with
factor product) bleeding episodes within 24 weeks before screening (visit 1).
- Patients with congenital haemophilia with inhibitors treated with FEIBA® prophylaxis:
greater than or equal to 2 treated bleeding episodes within 24 weeks before screening
(visit 1).
Exclusion Criteria:
- Known or suspected hypersensitivity to monoclonal antibodies.
- Previous participation in this study. Participation is defined as signed informed
consent.
- 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.
- Previous treatment with concizumab. Previous treatment is defined as two or more doses
administered.
- Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.
- Current or planned treatment with emicizumab.
- Any known congenital or acquired coagulation disorder other than congenital
haemophilia
We found this trial at
20
sites
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