Phase 2 N=19 Other

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

Bottom Line

View on ClinicalTrials.gov: NCT02541942 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jan 2019

Primary outcome: Primary: Determination of HLA Type — 15; 5; 5; 1 subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: No treatment given (Other)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: Male
Sponsor: Novo Nordisk A/S
Primary completion: Apr 2016

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.