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

Phase 2

Completed

• Conditions: Haemophilia A With Inhibitors; Congenital Bleeding Disorder; Haemophilia B With Inhibitors
• Interventions: Other: No treatment given

• Registration Number: NCT02541942
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-03
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Primary Completion: 2016-04-15
• Study Completion: 2016-04-15
• Results First Submitted: 2017-03-31
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-10
• Last Update Submitted: 2018-07-10
• Results First Posted: 2019-01-04
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Collection of specimen	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Determination of HLA Type	Up to 12 months	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.
Determination of Polymorphisms in the FVII Gene	Up to 12 months	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.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇭 Bangkok, Thailand