Trial Outcomes & Findings for Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial (NCT NCT02541942)
NCT ID: NCT02541942
Last Updated: 2019-01-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2019-01-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial
Baseline characteristics by cohort
| Measure |
Subjects for Analysis
n=19 Participants
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.
|
|---|---|
|
Age, Continuous
|
25.26 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
4 Participants
n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: All enrolled patients
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.
Outcome measures
| Measure |
Subjects for Analysis
n=19 Participants
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.
|
|---|---|
|
Determination of HLA Type
HLA-DRB1*13:05
|
1 subjects
|
|
Determination of HLA Type
HLA-DPA1*01:03
|
15 subjects
|
|
Determination of HLA Type
HLA-DPA1*02:01
|
5 subjects
|
|
Determination of HLA Type
HLA-DPA1*02:02
|
5 subjects
|
|
Determination of HLA Type
HLA-DPB1*01:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DPB1*02:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DPB1*03:01
|
3 subjects
|
|
Determination of HLA Type
HLA-DPB1*04:01
|
11 subjects
|
|
Determination of HLA Type
HLA-DPB1*04:02
|
6 subjects
|
|
Determination of HLA Type
HLA-DPB1*05:01
|
4 subjects
|
|
Determination of HLA Type
HLA-DPB1*09:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DPB1*11:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DPB1*13:01
|
2 subjects
|
|
Determination of HLA Type
HLA-DPB1*14:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DPB1*17:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DPB1*23:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DQA1*01:01
|
8 subjects
|
|
Determination of HLA Type
HLA-DQA1*01:02
|
5 subjects
|
|
Determination of HLA Type
HLA-DQA1*01:03
|
3 subjects
|
|
Determination of HLA Type
HLA-DQA1*02:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DQA1*03:01
|
6 subjects
|
|
Determination of HLA Type
HLA-DQA1*04:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DQA1*05:01
|
7 subjects
|
|
Determination of HLA Type
HLA-DQB1*02:01
|
3 subjects
|
|
Determination of HLA Type
HLA-DQB1*02:02
|
1 subjects
|
|
Determination of HLA Type
HLA-DQB1*03:01
|
4 subjects
|
|
Determination of HLA Type
HLA-DQB1*03:02
|
3 subjects
|
|
Determination of HLA Type
HLA-DQB1*03:03
|
1 subjects
|
|
Determination of HLA Type
HLA-DQB1*04:01
|
2 subjects
|
|
Determination of HLA Type
HLA-DQB1*04:02
|
2 subjects
|
|
Determination of HLA Type
HLA-DQB1*05:01
|
7 subjects
|
|
Determination of HLA Type
HLA-DQB1*05:02
|
2 subjects
|
|
Determination of HLA Type
HLA-DQB1*05:03
|
1 subjects
|
|
Determination of HLA Type
HLA-DQB1*06:02
|
2 subjects
|
|
Determination of HLA Type
HLA-DQB1*06:03
|
3 subjects
|
|
Determination of HLA Type
HLA-DQB1*06:04
|
1 subjects
|
|
Determination of HLA Type
HLA-DQB1*06:09
|
1 subjects
|
|
Determination of HLA Type
HLA-DRB1*01:01
|
3 subjects
|
|
Determination of HLA Type
HLA-DRB1*01:02
|
1 subjects
|
|
Determination of HLA Type
HLA-DRB1*03:01
|
3 subjects
|
|
Determination of HLA Type
HLA-DRB1*04:03
|
1 subjects
|
|
Determination of HLA Type
HLA-DRB1*04:04
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*04:05
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*07:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DRB1*08:02
|
1 subjects
|
|
Determination of HLA Type
HLA-DRB1*08:04
|
1 subjects
|
|
Determination of HLA Type
HLA-DRB1*09:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DRB1*10:01
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*11:01
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*11:04
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*13:01
|
3 subjects
|
|
Determination of HLA Type
HLA-DRB1*13:02
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*14:01
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*15:01
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*15:02
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB1*16:01
|
1 subjects
|
|
Determination of HLA Type
HLA-DRB3*01:01
|
5 subjects
|
|
Determination of HLA Type
HLA-DRB3*02:02
|
5 subjects
|
|
Determination of HLA Type
HLA-DRB3*03:01
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB4*01:01
|
5 subjects
|
|
Determination of HLA Type
HLA-DRB5*01:01
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB5*01:02
|
2 subjects
|
|
Determination of HLA Type
HLA-DRB5*02:02
|
1 subjects
|
PRIMARY outcome
Timeframe: Up 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.
Outcome measures
| Measure |
Subjects for Analysis
n=19 Participants
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.
|
|---|---|
|
Determination of Polymorphisms in the FVII Gene
|
0 Number of polymorphism
|
Adverse Events
Subjects for Analysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER