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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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02541942
Enrollment
19
Registered
2015-09-04
Start date
2015-04-03
Completion date
2016-04-15
Last updated
2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

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.

Interventions

OTHERNo treatment given

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

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of HLA TypeUp to 12 monthsHLA 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 GeneUp to 12 monthsDetermination 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.

Countries

Greece, Japan, Malaysia, Romania, Serbia, Thailand, United States

Participant flow

Recruitment details

The trial was conducted at 16 sites in 7 countries, as follows: Greece: 2 sites; Japan: 3 sites; Malaysia: 1 site, Romania 1 site, Serbia: 2 sites; Thailand: 2 sites; United States: 5 sites.

Pre-assignment details

This trial describes pharmacogenetic testing of saliva samples from patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue.

Participants by arm

ArmCount
Subjects for Analysis
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, were included in this arm.
19
Total19

Baseline characteristics

CharacteristicSubjects for Analysis
Age, Continuous25.26 years
STANDARD_DEVIATION 11.69
Age, Customized
Adolescents (12-17 years)
4 Participants
Age, Customized
Adults (18-64 years)
15 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
19 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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

Population: All enrolled patients

ArmMeasureGroupValue (NUMBER)
Subjects for AnalysisDetermination of HLA TypeHLA-DPA1*01:0315 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPA1*02:015 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPA1*02:025 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*01:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*02:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*03:013 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*04:0111 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*04:026 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*05:014 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*09:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*11:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*13:012 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*14:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*17:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DPB1*23:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQA1*01:018 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQA1*01:025 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQA1*01:033 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQA1*02:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQA1*03:016 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQA1*04:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQA1*05:017 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*02:013 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*02:021 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*03:014 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*03:023 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*03:031 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*04:012 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*04:022 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*05:017 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*05:022 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*05:031 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*06:022 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*06:033 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*06:041 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DQB1*06:091 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*01:013 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*01:021 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB5*01:012 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB5*01:022 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*03:013 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*04:031 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*04:042 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*04:052 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*07:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*08:021 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*08:041 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*09:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*10:012 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*11:012 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*11:042 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB5*02:021 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*13:013 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*13:022 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*13:051 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*14:012 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*15:012 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*15:022 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB1*16:011 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB3*01:015 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB3*02:025 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB3*03:012 subjects
Subjects for AnalysisDetermination of HLA TypeHLA-DRB4*01:015 subjects
Primary

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

ArmMeasureValue (NUMBER)
Subjects for AnalysisDetermination of Polymorphisms in the FVII Gene0 Number of polymorphism

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026