Clinical Trial Results:
Pharmacogenetic testing of saliva samples from patients with ≥5 exposure days to rFVIIa analogue in the adept™2 trial.
Summary
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EudraCT number |
2015-001919-13 |
Trial protocol |
RO |
Global end of trial date |
15 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Oct 2016
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First version publication date |
30 Oct 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NN1731-4214
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02541942 | ||
WHO universal trial number (UTN) |
U1111-1169-6103 | ||
Sponsors
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Sponsor organisation name |
Novo Nordisk A/S
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Sponsor organisation address |
Novo Allé, Bagsvaerd, Denmark, 2880
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Public contact |
Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
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Scientific contact |
Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Sep 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Apr 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Apr 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the HLA type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue in the adeptTM2 trial.
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Protection of trial subjects |
The trial was approved by local IRBs/IECs before collection of saliva samples. Health authority approval was only requested in Romania.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Apr 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 5
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Country: Number of subjects enrolled |
Greece: 4
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Country: Number of subjects enrolled |
Serbia: 2
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Country: Number of subjects enrolled |
Romania: 1
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Country: Number of subjects enrolled |
Malaysia: 1
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Country: Number of subjects enrolled |
Thailand: 3
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Country: Number of subjects enrolled |
Japan: 3
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Worldwide total number of subjects |
19
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EEA total number of subjects |
5
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
4
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Adults (18-64 years) |
15
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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Screening 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. | ||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not Applicable
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Arms
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Arm title
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Subjects for analysis | ||||||
Arm 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. | ||||||
Arm type |
No treatment given | ||||||
Investigational medicinal product name |
No treatment given
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Not mentioned
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Dosage and administration details |
No treatment given
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Subjects for analysis
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Reporting 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. |
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End point title |
To determine the HLA type in patients previously exposed to rFVIIa analogue in the adeptTM2 trial. [1] | ||||||
End point description |
Determination of HLA type 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.
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End point type |
Primary
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End point timeframe |
Up to 12 months
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There was no statistical analysis planned in the protocol for this trial. |
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Notes [2] - Results from this trial is communicated in conjunction with the NN1731-3562 trial. |
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No statistical analyses for this end point |
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End point title |
To determine the polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue in the adeptTM2 trial. [3] | ||||||
End point 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.
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End point type |
Primary
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End point timeframe |
Up to 12 months
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There was no statistical analysis planned in the protocol for this trial. |
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Notes [4] - No FVII variation/mutation was found in any of the 19 subjects. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
This is a bio-specimen research study. There is no safety analysis done in this trial.
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Adverse event reporting additional description |
Not Applicable.
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
Not Applicable (NA). | ||
Dictionary version |
NA
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: This is a bio-specimen research study. There is no safety analysis done in this trial. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |