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

July 10, 2018 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR 54642
        • Novo Nordisk Investigational Site
  • Japan
      • Kashihara-shi, Nara, Japan, 634 8522
        • Novo Nordisk Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 160 0023
        • Novo Nordisk Investigational Site
      • Suginami-ku, Tokyo, Japan, 167 0035
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300011
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
      • Novi Sad, Serbia, 21000
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-0001
        • Novo Nordisk Investigational Site
    • Florida
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Collection of specimen
Other: No treatment given
For patient convenience, genetic material will be collected in the form of saliva samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of HLA Type
Time Frame: 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.
Up to 12 months
Determination of Polymorphisms in the FVII Gene
Time Frame: 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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2015

Primary Completion (Actual)

April 15, 2016

Study Completion (Actual)

April 15, 2016

Study Registration Dates

First Submitted

August 19, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1731-4214
  • 2015-001919-13 (EudraCT Number)
  • U1111-1169-6103 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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