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

Phase 2CompletedNCT02541942

Novo Nordisk A/S19 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Interventions

No treatment givenOTHER

For patient convenience, genetic material will be collected in the form of saliva samples.

Eligibility

Sex: MALEMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (15)

Novo Nordisk Investigational Site

Tucson, Arizona, United States

Novo Nordisk Investigational Site

Tampa, Florida, United States

Novo Nordisk Investigational Site

Outcomes

Primary Outcomes

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.

Time frame: Up to 12 months

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.

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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