A Phase 2 interventional study of No treatment given in Congenital Bleeding Disorder, Haemophilia A With Inhibitors and Haemophilia B With Inhibitors, sponsored by Novo Nordisk A/S. Completed at 15 sites in 7 countries. Open to male participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Other
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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This study's enrollment of 19 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.
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Inclusion Criteria:
Other: No treatment given
For patient convenience, genetic material will be collected in the form of saliva samples.
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
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
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.
| Milestone | Subjects for Analysis |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
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.
| subjects | Subjects for Analysis |
|---|---|
| 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 |
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.
| Number of polymorphism | Subjects for Analysis |
|---|---|
| Determination of Polymorphisms in the FVII Gene | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects for Analysis | — | — | — |
| Age, Continuous(years) | Subjects for Analysis |
|---|---|
| Mean | 25.26 ± 11.69 |
| Age, Customized(Participants) | Subjects for Analysis |
|---|---|
| Adolescents (12-17 years) | 4 |
| Adults (18-64 years) | 15 |
| Sex: Female, Male(Participants) | Subjects for Analysis |
|---|---|
| Female | 0 |
| Male | 19 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S