Phase 2
Completed N=19
Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial
Congenital Bleeding Disorder · Haemophilia A With Inhibitors · Haemophilia B With Inhibitors
Source: ClinicalTrials.gov NCT02541942 ↗
Enrolled (actual)
19
Serious AEs
—
Results posted
Jan 2019
Primary outcomePrimary: Determination of HLA Type — 15; 5; 5; 1 subjects
Summary
This study is conducted globally. This study describes pharmacogenetic testing of saliva samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determination of HLA Type |
15; 5; 5; 1; 1; 3 | — |
| PRIMARY Determination of Polymorphisms in the FVII Gene |
— | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained before collection of saliva samples
- Previous participation in adept™2 trial with 5 or more exposure days to rFVIIa analogue
Data sourced from ClinicalTrials.gov (NCT02541942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.