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NCT02541942 Clinical Trial

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

Congenital Bleeding Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02541942
Other study ID # NN1731-4214
Secondary ID 2015-001919-13U1
Status Completed
Phase Phase 2
First received
Last updated
Start date April 3, 2015
Est. completion date April 15, 2016

Study information
Verified date July 2018
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date April 15, 2016
Est. primary completion date April 15, 2016
Accepts healthy volunteers No
Gender Male
Age group 12 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No treatment given
For patient convenience, genetic material will be collected in the form of saliva samples.

Locations
Country Name City State
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Thessaloniki
Japan Novo Nordisk Investigational Site Kashihara-shi, Nara
Japan Novo Nordisk Investigational Site Shinjuku-ku, Tokyo
Japan Novo Nordisk Investigational Site Suginami-ku, Tokyo
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
Romania Novo Nordisk Investigational Site Timisoara Timis
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Novi Sad
Thailand Novo Nordisk Investigational Site Bangkok
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Boston Massachusetts
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Greece,  Japan,  Malaysia,  Romania,  Serbia,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determination of HLA Type HLA typing includes up to 8 different HLA types (HLA-DRB1/B3/B4/B5, DPA1/B1 and DQA1/B1) and their most likely alleles. Number of participants with most likely HLA allele are reported. Up to 12 months
Primary Determination of Polymorphisms in the FVII Gene Determination of polymorphisms in the FVII gene in patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa. Up to 12 months
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