Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02541942
Collaborator
(none)
19
15
1
12.4
1.3
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept 2 Trial
Actual Study Start Date
:
Apr 3, 2015
Actual Primary Completion Date
:
Apr 15, 2016
Actual Study Completion Date
:
Apr 15, 2016
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Determination of HLA Type [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.
- Determination of Polymorphisms in the FVII Gene [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
Male
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Tucson | Arizona | United States | 85724-0001 |
| 2 | Novo Nordisk Investigational Site | Tampa | Florida | United States | 33607 |
| 3 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30322 |
| 4 | Novo Nordisk Investigational Site | Iowa City | Iowa | United States | 52242 |
| 5 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02115 |
| 6 | Novo Nordisk Investigational Site | Athens | Greece | GR-11527 | |
| 7 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR 54642 | |
| 8 | Novo Nordisk Investigational Site | Kashihara-shi, Nara | Japan | 634 8522 | |
| 9 | Novo Nordisk Investigational Site | Shinjuku-ku, Tokyo | Japan | 160 0023 | |
| 10 | Novo Nordisk Investigational Site | Suginami-ku, Tokyo | Japan | 167 0035 | |
| 11 | Novo Nordisk Investigational Site | Kuala Lumpur | Malaysia | 50400 | |
| 12 | Novo Nordisk Investigational Site | Timisoara | Timis | Romania | 300011 |
| 13 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11000 | |
| 14 | Novo Nordisk Investigational Site | Novi Sad | Serbia | 21000 | |
| 15 | Novo Nordisk Investigational Site | Bangkok | Thailand | 10400 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02541942
Other Study ID Numbers:
- NN1731-4214
- 2015-001919-13
- U1111-1169-6103
First Posted:
Sep 4, 2015
Last Update Posted:
Jan 4, 2019
Last Verified:
Jul 1, 2018
Additional relevant MeSH terms:
Study Results
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 Detail | 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. |
| Arm/Group Title | Subjects for Analysis |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 19 |
| COMPLETED | 19 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Subjects for Analysis |
|---|---|
| Arm/Group Description | 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 Participants | 19 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
25.26
(11.69)
|
| Age, Customized (Number) [Number] | |
| Adolescents (12-17 years) |
4
21.1%
|
| Adults (18-64 years) |
15
78.9%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
19
100%
|
Outcome Measures
| Title | Determination of HLA Type |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled patients |
| Arm/Group Title | Subjects for Analysis |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 19 |
| HLA-DPA1*01:03 |
15
|
| HLA-DPA1*02:01 |
5
|
| HLA-DPA1*02:02 |
5
|
| HLA-DPB1*01:01 |
1
|
| HLA-DPB1*02:01 |
1
|
| HLA-DPB1*03:01 |
3
|
| HLA-DPB1*04:01 |
11
|
| HLA-DPB1*04:02 |
6
|
| HLA-DPB1*05:01 |
4
|
| HLA-DPB1*09:01 |
1
|
| HLA-DPB1*11:01 |
1
|
| HLA-DPB1*13:01 |
2
|
| HLA-DPB1*14:01 |
1
|
| HLA-DPB1*17:01 |
1
|
| HLA-DPB1*23:01 |
1
|
| HLA-DQA1*01:01 |
8
|
| HLA-DQA1*01:02 |
5
|
| HLA-DQA1*01:03 |
3
|
| HLA-DQA1*02:01 |
1
|
| HLA-DQA1*03:01 |
6
|
| HLA-DQA1*04:01 |
1
|
| HLA-DQA1*05:01 |
7
|
| HLA-DQB1*02:01 |
3
|
| HLA-DQB1*02:02 |
1
|
| HLA-DQB1*03:01 |
4
|
| HLA-DQB1*03:02 |
3
|
| HLA-DQB1*03:03 |
1
|
| HLA-DQB1*04:01 |
2
|
| HLA-DQB1*04:02 |
2
|
| HLA-DQB1*05:01 |
7
|
| HLA-DQB1*05:02 |
2
|
| HLA-DQB1*05:03 |
1
|
| HLA-DQB1*06:02 |
2
|
| HLA-DQB1*06:03 |
3
|
| HLA-DQB1*06:04 |
1
|
| HLA-DQB1*06:09 |
1
|
| HLA-DRB1*01:01 |
3
|
| HLA-DRB1*01:02 |
1
|
| HLA-DRB1*03:01 |
3
|
| HLA-DRB1*04:03 |
1
|
| HLA-DRB1*04:04 |
2
|
| HLA-DRB1*04:05 |
2
|
| HLA-DRB1*07:01 |
1
|
| HLA-DRB1*08:02 |
1
|
| HLA-DRB1*08:04 |
1
|
| HLA-DRB1*09:01 |
1
|
| HLA-DRB1*10:01 |
2
|
| HLA-DRB1*11:01 |
2
|
| HLA-DRB1*11:04 |
2
|
| HLA-DRB1*13:01 |
3
|
| HLA-DRB1*13:02 |
2
|
| HLA-DRB1*13:05 |
1
|
| HLA-DRB1*14:01 |
2
|
| HLA-DRB1*15:01 |
2
|
| HLA-DRB1*15:02 |
2
|
| HLA-DRB1*16:01 |
1
|
| HLA-DRB3*01:01 |
5
|
| HLA-DRB3*02:02 |
5
|
| HLA-DRB3*03:01 |
2
|
| HLA-DRB4*01:01 |
5
|
| HLA-DRB5*01:01 |
2
|
| HLA-DRB5*01:02 |
2
|
| HLA-DRB5*02:02 |
1
|
| Title | Determination of Polymorphisms in the FVII Gene |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Subjects for Analysis |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 19 |
| Number [Number of polymorphism] |
0
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | This is a bio-specimen research study. There is no safety data collected and no analysis done in this trial. | |
| Arm/Group Title | Subjects for Analysis | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Subjects for Analysis | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Subjects for Analysis | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Subjects for Analysis | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Public Access to Clinical Trials |
|---|---|
| Organization | Novo Nordisk A/S |
| Phone | |
| clinicaltrials@novonordisk.com |
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02541942
Other Study ID Numbers:
- NN1731-4214
- 2015-001919-13
- U1111-1169-6103
First Posted:
Sep 4, 2015
Last Update Posted:
Jan 4, 2019
Last Verified:
Jul 1, 2018