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

NCT ID: NCT02541942

Last Updated: 2019-01-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-03

Study Completion Date

2016-04-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Collection of specimen

Group Type OTHER

No treatment given

Intervention Type OTHER

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

Interventions

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No treatment given

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Tucson, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Tampa, Florida, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Site Status

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Kashihara-shi, Nara, , Japan

Site Status

Novo Nordisk Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Suginami-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Kuala Lumpur, , Malaysia

Site Status

Novo Nordisk Investigational Site

Timișoara, Timiș County, Romania

Site Status

Novo Nordisk Investigational Site

Belgrade, , Serbia

Site Status

Novo Nordisk Investigational Site

Novi Sad, , Serbia

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Countries

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United States Greece Japan Malaysia Romania Serbia Thailand

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2015-001919-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1169-6103

Identifier Type: OTHER

Identifier Source: secondary_id

NN1731-4214

Identifier Type: -

Identifier Source: org_study_id

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