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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach

7 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

April 3, 2015

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed

16 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2016

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

January 4, 2019

Completed

Last Updated

January 4, 2019

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

August 19, 2015

Results QC Date

March 31, 2017

Last Update Submit

July 10, 2018

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (2)

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
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

Study Arms (1)

Collection of specimen

OTHER

Other: No treatment given

Interventions

No treatment givenOTHER

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

Collection of specimen

Eligibility Criteria

Age12 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Informed consent obtained before collection of saliva samples
Previous participation in adept™2 trial with 5 or more exposure days to rFVIIa analogue

Contact the study team to confirm eligibility.