At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
No treatment givenother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept 2 Trial
In Brief
A Phase 2 clinical trial evaluating No treatment given for Congenital Bleeding Disorder and 2 related conditions. Completed, enrolled 19 participants across 15 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
CountriesGreece, Japan, Malaysia, Romania, Serbia, Thailand, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedSep 2015
Primary CompletionApr 2016
TodayJul 2026
First PostedSep 4, 2015
Enrollment StartApr 3, 2015
Primary CompletionApr 15, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.8 years ago
Interventions
No treatment givenother
For patient convenience, genetic material will be collected in the form of saliva samples.