Pharmacogenetic testing of saliva samples from patients in the adept™2 trial (NN1731-3562)
Phase 1
- Conditions
- - Haemophilia A with inhibitors- Haemophilia B with inhibitorsMedDRA version: 18.1Level: PTClassification code 10056492Term: Haemophilia A with anti factor VIIISystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 18.1Level: PTClassification code 10056494Term: Haemophilia B with anti factor IXSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2015-001919-13-RO
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 28
Inclusion Criteria
1. Informed consent obtained before collection of saliva samples
2. Previous participation in adept™2 trial with =5 exposure days to rFVIIa analogue
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
No exclusion criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable;Main Objective: To determine the HLA type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue in the adept™2 trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable