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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001919-13 | EudraCT Number | ||
| U1111-1169-6103 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collection of specimen | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | For patient convenience, genetic material will be collected in the form of saliva samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tucson | Arizona | 85724-0001 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tampa |
| Florida |
| 33607 |
| United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30322 | United States |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02115 | United States |
| Novo Nordisk Investigational Site | Athens | GR-11527 | Greece |
| Novo Nordisk Investigational Site | Thessaloniki | GR 54642 | Greece |
| Novo Nordisk Investigational Site | Kashihara-shi, Nara | 634 8522 | Japan |
| Novo Nordisk Investigational Site | Shinjuku-ku, Tokyo | 160 0023 | Japan |
| Novo Nordisk Investigational Site | Suginami-ku, Tokyo | 167 0035 | Japan |
| Novo Nordisk Investigational Site | Kuala Lumpur | 50400 | Malaysia |
| Novo Nordisk Investigational Site | Timișoara | Timiș County | 300011 | Romania |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia |
| Novo Nordisk Investigational Site | Novi Sad | 21000 | Serbia |
| Novo Nordisk Investigational Site | Bangkok | 10400 | Thailand |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This table reflects the age of the patients when entering the preceding main triall NN1731-3562. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Age, Customized | This table reflects the age of the patients when entering the preceding main trial NN1731-3562. | Number | Participants |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All enrolled patients | Posted | Number | subjects | Up to 12 months |
|
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| ||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | Number of polymorphism | Up to 12 months |
|
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This is a bio-specimen research study. There is no safety data collected and no analysis done in this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| Title | Measurements |
|---|---|
|
| HLA-DPB1*01:01 |
|
| HLA-DPB1*02:01 |
|
| HLA-DPB1*03:01 |
|
| HLA-DPB1*04:01 |
|
| HLA-DPB1*04:02 |
|
| HLA-DPB1*05:01 |
|
| HLA-DPB1*09:01 |
|
| HLA-DPB1*11:01 |
|
| HLA-DPB1*13:01 |
|
| HLA-DPB1*14:01 |
|
| HLA-DPB1*17:01 |
|
| HLA-DPB1*23:01 |
|
| HLA-DQA1*01:01 |
|
| HLA-DQA1*01:02 |
|
| HLA-DQA1*01:03 |
|
| HLA-DQA1*02:01 |
|
| HLA-DQA1*03:01 |
|
| HLA-DQA1*04:01 |
|
| HLA-DQA1*05:01 |
|
| HLA-DQB1*02:01 |
|
| HLA-DQB1*02:02 |
|
| HLA-DQB1*03:01 |
|
| HLA-DQB1*03:02 |
|
| HLA-DQB1*03:03 |
|
| HLA-DQB1*04:01 |
|
| HLA-DQB1*04:02 |
|
| HLA-DQB1*05:01 |
|
| HLA-DQB1*05:02 |
|
| HLA-DQB1*05:03 |
|
| HLA-DQB1*06:02 |
|
| HLA-DQB1*06:03 |
|
| HLA-DQB1*06:04 |
|
| HLA-DQB1*06:09 |
|
| HLA-DRB1*01:01 |
|
| HLA-DRB1*01:02 |
|
| HLA-DRB1*03:01 |
|
| HLA-DRB1*04:03 |
|
| HLA-DRB1*04:04 |
|
| HLA-DRB1*04:05 |
|
| HLA-DRB1*07:01 |
|
| HLA-DRB1*08:02 |
|
| HLA-DRB1*08:04 |
|
| HLA-DRB1*09:01 |
|
| HLA-DRB1*10:01 |
|
| HLA-DRB1*11:01 |
|
| HLA-DRB1*11:04 |
|
| HLA-DRB1*13:01 |
|
| HLA-DRB1*13:02 |
|
| HLA-DRB1*13:05 |
|
| HLA-DRB1*14:01 |
|
| HLA-DRB1*15:01 |
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| HLA-DRB1*15:02 |
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| HLA-DRB1*16:01 |
|
| HLA-DRB3*01:01 |
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| HLA-DRB3*02:02 |
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| HLA-DRB3*03:01 |
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| HLA-DRB4*01:01 |
|
| HLA-DRB5*01:01 |
|
| HLA-DRB5*01:02 |
|
| HLA-DRB5*02:02 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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