Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial

Completed · Phase 2

Conditions studied: Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

In brief

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.

Key facts

Study ID

NCT02541942

Run by

Novo Nordisk A/S

People needed

19

Starts

2015-04-03

Expected to finish

2016-04-15

Last updated by the study team

2019-01-04

Who can join

Age: 12 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before collection of saliva samples
• Previous participation in adept™2 trial with 5 or more exposure days to rFVIIa analogue

Where it is running

• Novo Nordisk Investigational Site — Tucson, Arizona, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Boston, Massachusetts, United States
• Novo Nordisk Investigational Site — Athens, Greece
• Novo Nordisk Investigational Site — Thessaloniki, Greece
• Novo Nordisk Investigational Site — Kashihara-shi, Nara, Japan
• Novo Nordisk Investigational Site — Shinjuku-ku, Tokyo, Japan
• Novo Nordisk Investigational Site — Suginami-ku, Tokyo, Japan
• Novo Nordisk Investigational Site — Kuala Lumpur, Malaysia
• Novo Nordisk Investigational Site — Timișoara, Timiș County, Romania
• Novo Nordisk Investigational Site — Belgrade, Serbia
• Novo Nordisk Investigational Site — Novi Sad, Serbia
• Novo Nordisk Investigational Site — Bangkok, Thailand

Full record on ClinicalTrials.gov

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