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CompletedNCT01253811mentor™5Updated Jun 24, 2016Results posted

Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency

A Phase 3 interventional study of catridecacog in Congenital Bleeding Disorder and Congenital FXIII Deficiency, sponsored by Novo Nordisk A/S. Completed at 4 sites in 3 countries. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2016-06-24.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
1 Year to 6 Years
Sex
All
01

Study summary

This trial will be conducted in Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children aged between 1 and 6 years with congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4, NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on when recombinant factor XIII will be commercially available in subject's respective country for use in children of 1-6 years of age.

02

Conditions studied

  • Congenital Bleeding Disorder
  • Congenital FXIII Deficiency
03

In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's enrollment of 6 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Completed participation in trial F13CD-3760 (NCT01230021)

Exclusion criteria

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product or related products
  • Known history of development of inhibitors against FXIII (factor XIII)
  • Hereditary or acquired coagulation disorder other than FXIII congenital deficiency
  • Platelet count (thrombocytes) less than 50X10e9 / L
  • Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus
  • Previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis
  • Any disease or condition which, judged by the trial physician, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome including renal and/or liver dysfunction
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    rFXIII 35 IU/kg

    Drug: catridecacog

Interventions

  • Drugcatridecacog

    Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg body weight every 4th week

    Also known as: recombinant factor XIII

06

What researchers measure

Primary outcomes

  1. Number of Treatment Emergent (Serious and Non-serious) Adverse Events

    An adverse event was described as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (serious and non-serious), defined as adverse events occurring from first trial product administration to the end of the subject's participation in the trial.

    Time frame: Week 0 to end of trial visit (week 173) for a minimum period of 52 weeks.

Secondary outcomes

  1. Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors.

    All subjects who received rFXIII were monitored for the frequency of development of anti-rFXIII antibodies. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including \~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors.

    Time frame: Week 0 to end of trial visit (week 173).

  2. Clinical Laboratory Assessments: Biochemistry: Creatinine

    Clinical laboratory assessments for creatinine at week 24 to end of trial visit.

    Time frame: Every 6th month, from week 24 to end of trial visit (week 173).

  3. Clinical Laboratory Assessments: Biochemistry: Urea

    Clinical laboratory assessments for urea at week 24 to end ot trial visit.

    Time frame: Every 6th month, week 24 to end of trial visit (week 173).

  4. Clinical Laboratory Assessments: Biochemistry: Alanine Aminotransferase (ALAT)

    Clinical laboratory assessments for ALAT at week 24 to end of trial visit.

    Time frame: Every 6th month, from week 24 to end of trial visit (week 173).

  5. Clinical Laboratory Assessments: Biochemistry: Aspartate Aminotransferase (ASAT)

    Clinical laboratory assessments for ASAT at week 24 to end of trial visit.

    Time frame: Every 6th month, from week 24 to end of trial visit (week 173).

  6. Clinical Laboratory Assessments: Haematology: Haemoglobin

    Clinical values for haemoglobin collected from week 0 to end of trial visit.

    Time frame: Every 6th month, from week 0 to end of trial visit (week 173).

  7. Clinical Laboratory Assessments: Haematology: Leucocytes

    Clinical laboratory values for leucocytes collected from week 0 to end of trial visit.

    Time frame: Every 6th month, from week 0 to end of trial visit (week 173).

  8. Clinical Laboratory Assessments: Haematology: Thrombocytes

    Clinical laboratory values for thrombocytes collected from week 0 to end of trial visit.

    Time frame: Every 6th month, from week 0 to end of trial visit (week 173).

  9. Clinical Laboratory Assessments: Haematology: Erythrocytes

    Clinical laboratory values for erythrocytes collected from week 0 to end of trial visit.

    Time frame: Every 6th month, from week 0 to end of trial visit (week 173).

  10. Clinical Laboratory Assessments: Haematology: Haematocrit

    Clinical laboratory values for haematocrit collected from week 0 to end of trial visit.

    Time frame: Every 6th month, from week 0 to end of trial visit (week 173).

  11. Physical Examinations

    Number of subjects in percentage with changes in values of physical examinations from week 0 to end of trial visit were collected.

    Time frame: Week 0 to end of trial visit (week 173).

  12. Vital Signs: Systolic BP (Blood Pressure)

    Values collected for systolic BP from week 0 to end of trial visit.

    Time frame: Week 0 to end of trial visit (week 173).

  13. Vital Signs: Diastolic BP (Blood Pressure)

    Values collected for diastolic BP from week 0 to end of trial visit.

    Time frame: Week 0 to end of trial visit (week 173).

  14. Vital Signs: Pulse

    Values collected for pulse from week 0 to end of trial visit.

    Time frame: Week 0 to end of trial visit (week 173).

  15. Rate (Number Per Subject Year) of All Bleeding Episodes Requiring Treatment With a FXIII Containing Product Other Than Recombinant Factor XIII.

    The rate (number per subject year) of all spontaneous, traumatic and intracranial bleeding episodes requiring treatment with FXIII-containing products during the rFXIII treatment period was assessed for treatment period.

    Time frame: Weeks 0 to end of trial visit (week 173).

07

Results

Posted Jun 24, 2016
Limitations and caveats
Limitations of the trial included the small number of subjects analysed and the sensitivity of the Berichrom® FXIII activity assay. However, congenital FXIII deficiency is a rare disease and there were no bleeds requiring haemostatic treatment.

Participant flow

The trial was conducted at 5 sites in 3 countries as follows: Israel (IS): 1 site; United Kingdom (UK): 2 sites; and United States (US): 2 sites.

Participant flow — Overall Study
MilestonerFXIII 35 IU/kg
Started6
Exposed6
Completed5
Not completed1
Withdrew: Withdrawal criteria1

Outcome measures

PrimaryNumber of Treatment Emergent (Serious and Non-serious) Adverse Events

An adverse event was described as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (serious and non-serious), defined as adverse events occurring from first trial product administration to the end of the subject's participation in the trial.

Time frame:
Week 0 to end of trial visit (week 173) for a minimum period of 52 weeks.
Reported as:
Number · number of events
Number of Treatment Emergent (Serious and Non-serious) Adverse Events
number of eventsrFXIII 35 IU/kg
All adverse events100
Serious adverse events2
Non-serious adverse events98
SecondaryPercentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors.

All subjects who received rFXIII were monitored for the frequency of development of anti-rFXIII antibodies. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including \~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors.

Time frame:
Week 0 to end of trial visit (week 173).
Reported as:
Number · percentage of subjects
Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors.
percentage of subjectsrFXIII 35 IU/kg
Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors.0
SecondaryClinical Laboratory Assessments: Biochemistry: Creatinine

Clinical laboratory assessments for creatinine at week 24 to end of trial visit.

Time frame:
Every 6th month, from week 24 to end of trial visit (week 173).
Reported as:
Mean · mmol/L
Clinical Laboratory Assessments: Biochemistry: Creatinine
mmol/LrFXIII 35 IU/kg
Week 24 (pre-dose), N=530.20 ± 8.23
Week 48 (pre-dose), N=528.00 ± 6.16
Week 72 (pre-dose), N=628.67 ± 5.13
Week 96 (pre-dose), N=537.00 ± 4.74
Week 120 (pre-dose), N=431.50 ± 5.92
Week 144 (pre-dose), N=331.00 ± 6.00
Week 168 (pre-dose), N=155.00 ± 0.00
End of trial (week 173) pre-dose, N= 635.17 ± 9.79
SecondaryClinical Laboratory Assessments: Biochemistry: Urea

Clinical laboratory assessments for urea at week 24 to end ot trial visit.

Time frame:
Every 6th month, week 24 to end of trial visit (week 173).
Reported as:
Mean · mmol/L
Clinical Laboratory Assessments: Biochemistry: Urea
mmol/LrFXIII 35 IU/kg
Week 24 (pre-dose), N=55.50 ± 1.63
Week 48 (pre-dose), N=54.00 ± 1.22
Week 72 (pre-dose), N=63.99 ± 0.69
Week 96 (pre-dose), N=54.50 ± 1.14
Week 120 (pre-dose), N=43.48 ± 0.73
Week 144 (pre-dose), N=34.52 ± 1.35
Week 168 (pre-dose), N=15.00 ± 0.00
End of trial (week 173) pre-dose, N= 64.28 ± 0.84
SecondaryClinical Laboratory Assessments: Biochemistry: Alanine Aminotransferase (ALAT)

Clinical laboratory assessments for ALAT at week 24 to end of trial visit.

Time frame:
Every 6th month, from week 24 to end of trial visit (week 173).
Reported as:
Mean · IU/L
Clinical Laboratory Assessments: Biochemistry: Alanine Aminotransferase (ALAT)
IU/LrFXIII 35 IU/kg
Week 24 (pre-dose), N=417.75 ± 5.85
Week 48 (pre-dose), N=516.20 ± 2.39
Week 72 (pre-dose), N=516.40 ± 4.93
Week 96 (pre-dose), N=412.50 ± 3.70
Week 120 (pre-dose), N=321.33 ± 12.10
Week 144 (pre-dose), N=217.00 ± 1.41
Week 168 (pre-dose), N=114.00 ± 0.00
End of trial (week 173) pre-dose, N=516.00 ± 3.94
SecondaryClinical Laboratory Assessments: Biochemistry: Aspartate Aminotransferase (ASAT)

Clinical laboratory assessments for ASAT at week 24 to end of trial visit.

Time frame:
Every 6th month, from week 24 to end of trial visit (week 173).
Reported as:
Mean · IU/L
Clinical Laboratory Assessments: Biochemistry: Aspartate Aminotransferase (ASAT)
IU/LrFXIII 35 IU/kg
Week 24 (pre-dose), N=430.75 ± 5.68
Week 48 (pre-dose), N=538.20 ± 10.99
Week 72 (pre-dose), N=531.20 ± 8.11
Week 96 (pre-dose), N=426.25 ± 1.71
Week 120 (pre-dose), N=327.00 ± 3.00
Week 144(pre-dose), N=226.00 ± 1.41
Week 168 (pre-dose), N=125.00 ± 0.00
End of trial (week 173) pre-dose, N=528.00 ± 3.61
SecondaryClinical Laboratory Assessments: Haematology: Haemoglobin

Clinical values for haemoglobin collected from week 0 to end of trial visit.

Time frame:
Every 6th month, from week 0 to end of trial visit (week 173).
Reported as:
Mean · mmol/L
Clinical Laboratory Assessments: Haematology: Haemoglobin
mmol/LrFXIII 35 IU/kg
Week 0 (pre-dose), N=67.366 ± 0.25
Week 24 (pre-dose), N=47.624 ± 0.19
Week 48 (pre-dose), N=37.138 ± 0.31
Week 72 (pre-dose), N=37.262 ± 0.65
Week 96 (pre-dose), N=37.635 ± 0.27
Week 120 (pre-dose), N=37.821 ± 0.38
Week 144 (pre-dose), N=37.717 ± 0.70
Week 168 (pre-dose), N=27.759 ± 0.53
End of trial (week 173) pre-dose, N=68.048 ± 0.45
SecondaryClinical Laboratory Assessments: Haematology: Leucocytes

Clinical laboratory values for leucocytes collected from week 0 to end of trial visit.

Time frame:
Every 6th month, from week 0 to end of trial visit (week 173).
Reported as:
Mean · 10^9 cells/L
Clinical Laboratory Assessments: Haematology: Leucocytes
10^9 cells/LrFXIII 35 IU/kg
Week 0 (pre-dose), N=68.367 ± 2.20
Week 24 (pre-dose), N=47.373 ± 1.88
Week 48 (pre-dose), N=35.387 ± 1.06
Week 72 (pre-dose), N=45.863 ± 1.96
Week 96 (pre-dose), N=46.643 ± 1.89
Week 120(pre-dose), N=35.027 ± 2.12
Week 144(pre-dose), N=34.850 ± 3.00
Week 168(pre-dose), N=24.275 ± 2.65
End of trial (week 173) pre-dose, N=67.605 ± 1.25
SecondaryClinical Laboratory Assessments: Haematology: Thrombocytes

Clinical laboratory values for thrombocytes collected from week 0 to end of trial visit.

Time frame:
Every 6th month, from week 0 to end of trial visit (week 173).
Reported as:
Mean · 10^9 cells/L
Clinical Laboratory Assessments: Haematology: Thrombocytes
10^9 cells/LrFXIII 35 IU/kg
Week 0 (pre-dose), N=6316.3 ± 50.75
Week 24 (pre-dose), N=4296.0 ± 54.17
Week 48 (pre-dose), N=3277.0 ± 93.72
Week 72 (pre-dose), N=4283.3 ± 41.63
Week 96 (pre-dose), N=4332.3 ± 107.3
Week 120 (pre-dose), N=3269.7 ± 102.2
Week 144 (pre-dose), N=3324.3 ± 44.64
Week 168 (pre-dose), N=2307.0 ± 15.56
End of trial (week 173) pre-dose, N=6321.3 ± 60.45
SecondaryClinical Laboratory Assessments: Haematology: Erythrocytes

Clinical laboratory values for erythrocytes collected from week 0 to end of trial visit.

Time frame:
Every 6th month, from week 0 to end of trial visit (week 173).
Reported as:
Mean · 10^12 cells/L
Clinical Laboratory Assessments: Haematology: Erythrocytes
10^12 cells/LrFXIII 35 IU/kg
Week 0 (pre-dose), N=64.863 ± 0.43
Week 24 (pre-dose), N=44.745 ± 0.18
Week 48 (pre-dose), N=34.587 ± 0.12
Week 72 (pre-dose), N=44.505 ± 0.22
Week 96 (pre-dose), N=44.628 ± 0.26
Week 120 (pre-dose), N=34.247 ± 1.19
Week 144 (pre-dose), N=34.627 ± 0.11
Week 168 (pre-dose), N=24.875 ± 0.11
End of trial (week 173), N=64.662 ± 0.21
SecondaryClinical Laboratory Assessments: Haematology: Haematocrit

Clinical laboratory values for haematocrit collected from week 0 to end of trial visit.

Time frame:
Every 6th month, from week 0 to end of trial visit (week 173).
Reported as:
Mean · percentage of red blood cells
Clinical Laboratory Assessments: Haematology: Haematocrit
percentage of red blood cellsrFXIII 35 IU/kg
Week 0 (pre-dose), N=635.07 ± 0.99
Week 24 (pre-dose), N=436.05 ± 1.90
Week 48 (pre-dose), N=332.83 ± 1.76
Week 72 (pre-dose), N=434.80 ± 2.49
Week 96 (pre-dose), N=436.85 ± 1.07
Week 120 (pre-dose), N=332.83 ± 8.61
Week 144 (pre-dose), N=336.6 ± 3.44
Week 168 (pre-dose), N=236.40 ± 2.26
End of trial (week 173), N=637.45 ± 3.22
SecondaryPhysical Examinations

Number of subjects in percentage with changes in values of physical examinations from week 0 to end of trial visit were collected.

Time frame:
Week 0 to end of trial visit (week 173).
Reported as:
Number · percentage of subjects
Physical Examinations
percentage of subjectsrFXIII 35 IU/kg
Skin3
Musculo-skeletal system1
SecondaryVital Signs: Systolic BP (Blood Pressure)

Values collected for systolic BP from week 0 to end of trial visit.

Time frame:
Week 0 to end of trial visit (week 173).
Reported as:
Mean · mmHg
Vital Signs: Systolic BP (Blood Pressure)
mmHgrFXIII 35 IU/kg
Week 0, N=6107.0 ± 13.7
Week 4, N=6101.0 ± 8.4
Week 8, N=699.0 ± 9.4
Week 12, N=6106.3 ± 9.4
Week 16, N=6106.0 ± 4.1
Week 20, N=6100.7 ± 10.0
Week 24, N=6112.0 ± 12.6
Week 28, N=6101.3 ± 11.4
Week 32, N=6103.7 ± 20.6
Week 36, N=6102.3 ± 11.9
Week 40, N=699.7 ± 8.3
Week 44, N=699.7 ± 13.0
Week 48, N=6103.5 ± 19.4
Week 60, N=5105.4 ± 7.8
Week 72, N=6101.7 ± 7.3
Week 84, N=6100.7 ± 10.7
Week 96, N=5101.2 ± 4.8
Week 108, N=5109.6 ± 10.9
Week 120, N=4107.0 ± 7.0
Week 132, N=499.3 ± 6.2
Week 144, N=3101.7 ± 7.8
Week 156, N=3110.7 ± 7.0
Week 168, N=2107.0 ± 7.1
End of trial (week 173), N=696.5 ± 4.8
SecondaryVital Signs: Diastolic BP (Blood Pressure)

Values collected for diastolic BP from week 0 to end of trial visit.

Time frame:
Week 0 to end of trial visit (week 173).
Reported as:
Mean · mmHg
Vital Signs: Diastolic BP (Blood Pressure)
mmHgrFXIII 35 IU/kg
Week 0, N=664.0 ± 7.6
Week 4, N=662.7 ± 11.4
Week 8, N=658.3 ± 19.1
Week 12, N=657.5 ± 7.9
Week 16, N=652.0 ± 3.3
Week 20, N=665.2 ± 6.5
Week 24, N=664.0 ± 4.4
Week 28, N=658.3 ± 10.4
Week 32, N=661.7 ± 16.4
Week 36, N=666.2 ± 11.1
Week 40, N=662.5 ± 6.4
Week 44, N=660.3 ± 7.3
Week 48, N=664.7 ± 10.9
Week 60, N=569.4 ± 10.9
Week 72, N=658.2 ± 4.6
Week 84, N=657.5 ± 8.1
Week 96, N=562.0 ± 6.3
Week 108, N=557.6 ± 10.4
Week 120, N=462.0 ± 3.4
Week 132, N=455.8 ± 8.4
Week 144, N=352.0 ± 9.2
Week 156, N=357.7 ± 6.7
Week 168, N=253.5 ± 2.1
End of trial (week 173), N=656.2 ± 5.5
SecondaryVital Signs: Pulse

Values collected for pulse from week 0 to end of trial visit.

Time frame:
Week 0 to end of trial visit (week 173).
Reported as:
Mean · beats/minute
Vital Signs: Pulse
beats/minuterFXIII 35 IU/kg
Week 0, N=6113.2 ± 10.6
Week 4, N=697.7 ± 16.9
Week 8, N=6106.2 ± 4.6
Week 12, N=6104.5 ± 7.3
Week 16, N=6109.8 ± 9.8
Week 20, N=6105.3 ± 19.7
Week 24, N=6103.7 ± 6.4
Week 28, N=6102.2 ± 9.3
Week 32, N=6108.3 ± 20.5
Week 36, N=695.5 ± 22.2
Week 40, N=693.2 ± 19.5
Week 44, N=695.5 ± 23.2
Week 48, N=6100.5 ± 7.9
Week 60, N=5109.0 ± 15.1
Week 72, N=6100.8 ± 11.4
Week 84, N=699.3 ± 7.9
Week 96, N=496.5 ± 16.2
Week 108, N=598.4 ± 18.0
Week 120, N=485.0 ± 16.4
Week 132, N=486.3 ± 16.7
Week 144, N=388.0 ± 11.1
Week 156, N=3100.7 ± 11.0
Week 168, N=292.0 ± 9.9
End of trial (week 173), N=694.0 ± 16.8
SecondaryRate (Number Per Subject Year) of All Bleeding Episodes Requiring Treatment With a FXIII Containing Product Other Than Recombinant Factor XIII.

The rate (number per subject year) of all spontaneous, traumatic and intracranial bleeding episodes requiring treatment with FXIII-containing products during the rFXIII treatment period was assessed for treatment period.

Time frame:
Weeks 0 to end of trial visit (week 173).

No measurements were reported for this outcome.

Adverse events

Collected over All adverse events were collected and reported from screening (visit 1) and until the end of trial visit for a minimum period of 52 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
rFXIII 35 IU/kg—1/6 (16.7%)6/6 (100%)
Most frequent serious events
Most frequent serious events
EventrFXIII 35 IU/kg
Head injuryInjury, poisoning and procedural complications1/6
Most frequent other events
Showing 10 of 48
Most frequent other events
EventrFXIII 35 IU/kg
PyrexiaGeneral disorders4/6
DiarrhoeaGastrointestinal disorders3/6
Upper respiratory tract infectionInfections and infestations3/6
ContusionInjury, poisoning and procedural complications3/6
FallInjury, poisoning and procedural complications3/6
HeadacheNervous system disorders3/6
NauseaGastrointestinal disorders2/6
VomitingGastrointestinal disorders2/6
Infusion site extravasationGeneral disorders2/6
PainGeneral disorders2/6

Baseline characteristics

The safety analysis set (SAS) included all patients exposed to trial drug (rFXIII).

Age, Continuous
Age, Continuous(years)rFXIII 35 IU/kg
Mean3.0 ± 1.3
Sex: Female, Male
Sex: Female, Male(Participants)rFXIII 35 IU/kg
Female3
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)rFXIII 35 IU/kg
Hispanic or Latino0
Not Hispanic or Latino6
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)rFXIII 35 IU/kg
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American1
White2
More than one race0
Unknown or Not Reported0
08

Study locations

4 sites
  • Novo Nordisk Clinical Trial Call Center
    Boston, Massachusetts 02115, United States
  • Novo Nordisk Clinical Trial Call Center
    Columbus, Ohio 43205, United States
  • Petach Tikva, 49100, Israel
  • Leicester, LE1 5WW, United Kingdom
09

References and documents

Publications

  • Kerlin BA, Inbal A, Will A, Williams M, Garly ML, Jacobsen L, Kearney SL. Recombinant factor XIII prophylaxis is safe and effective in young children with congenital factor XIII-A deficiency: international phase 3b trial results. J Thromb Haemost. 2017 Aug;15(8):1601-1606. doi: 10.1111/jth.13748. Epub 2017 Jul 10. PubMed 28581691 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01253811
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 3, 2010
Start date
Jan 2011
Primary completion
Mar 2015
Completion
Mar 2015
Results posted
Jun 24, 2016
Last update
Jun 24, 2016

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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