An international investigator trial to capture different approaches in the treatment of Hemophilia A Patients With FVIII Inhibitors
- Conditions
- Inhibitor-Positive patients with Haemophilia AMedDRA version: 20.0Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2019-003427-38-FI
- Lead Sponsor
- HZRM – Hämophilie-Zentrum Rhein Main GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 120
1. Participants can be of any age at the time of enrolment
2. Persons with HA, of any severity, who have a historical inhibitor titre = 0.6 BU/mL, including those who have failed previous ITI attempt(s)
3. Persons undergoing ITI with Nuwiq®, octanate® or wilate® or undergoing ITI with Nuwiq®, octanate® or wilate® and receiving prophylactic therapy with emicizumab, aPCC or rFVIIa
4. Male
5. Participants or participants’ parent(s)/legal guardian(s) must be capable of giving signed informed consent and able to understand the trial documents
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- Participants are excluded from the trial if any coagulation disorder other than HA is diagnosed
- Partly retrospective patients will be excluded if detailed documentation on treatment, all BEs, inhibitor titres and FVIII levels is not available for the retrospective period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method