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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003148-51 | EudraCT Number |
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The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFXIII | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catridecacog | Drug | 35 IU/kg body weight, i.v. administration, once every 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period | It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product. | For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits | Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube). |
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Inclusion Criteria:
Exclusion 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 | Phoenix | Arizona | 85016-7710 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22451421 | Result | Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D. Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012 May 31;119(22):5111-7. doi: 10.1182/blood-2011-10-386045. Epub 2012 Mar 26. | |
| 25643920 | Result | Brand-Staufer B, Carcao M, Kerlin BA, Will A, Williams M, Tornoe CW, Sandberg Lundblad M, Nugent D. Pharmacokinetic characterization of recombinant factor XIII (FXIII)-A2 across age groups in patients with FXIII A-subunit congenital deficiency. Haemophilia. 2015 May;21(3):380-385. doi: 10.1111/hae.12616. Epub 2015 Jan 21. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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After screening, eligible subjects entered a 4-week run-in period followed by a 52-week recombinant factor XIII (rFXIII) treatment period. Subjects who before entering the trial were receiving regular replacement therapy with a FXIII-containing product were to receive their last standard replacement dose just before the screening visit.
Of a total of 29 initiated trial sites, 23 sites enrolled and dosed at least one patient. The country distribution was (number of actively recruiting sites per country in parenthesis): Austria (1), Canada (1), Finland (1), France (1), Germany (3), Israel (2), Italy (1), Spain (1), Switzerland (1), UK (3) and United States of America (8)
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| ID | Title | Description |
|---|---|---|
| FG000 | rFXIII | Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). |
| Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits | Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3). | For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). |
| Number of Subjects With rFXIII Antibody Development | Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit) | For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). |
| Orange |
| California |
| 92868 |
| United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33607 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30322 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02115 | United States |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48201 | United States |
| Novo Nordisk Investigational Site | East Lansing | Michigan | 48823 | United States |
| Novo Nordisk Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| Novo Nordisk Investigational Site | Columbus | Ohio | 43205 | United States |
| Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Novo Nordisk Investigational Site | Seattle | Washington | 98104 | United States |
| Novo Nordisk Investigational Site | Graz | 8036 | Austria |
| Novo Nordisk Investigational Site | Klagenfurt | A-9020 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1090 | Austria |
| Novo Nordisk Investigational Site | Toronto | Ontario | M5G 1X8 | Canada |
| Novo Nordisk Investigational Site | Helsinki | 00290 | Finland |
| Novo Nordisk Investigational Site | Le Kremlin-Bicêtre | 94270 | France |
| Novo Nordisk Investigational Site | Marseille | 13385 | France |
| Novo Nordisk Investigational Site | Montpellier | 34295 | France |
| Novo Nordisk Investigational Site | Bonn | 53127 | Germany |
| Novo Nordisk Investigational Site | Braunschweig | 38118 | Germany |
| Novo Nordisk Investigational Site | Duisburg | 47051 | Germany |
| Novo Nordisk Investigational Site | Petah Tikva | 49100 | Israel |
| Novo Nordisk Investigational Site | Tel Litwinsky | 52621 | Israel |
| Novo Nordisk Investigational Site | Vicenza | 36100 | Italy |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Seville | 41013 | Spain |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| Novo Nordisk Investigational Site | Aberdeen | AB25 2ZN | United Kingdom |
| Novo Nordisk Investigational Site | Birmingham | B4 6NH | United Kingdom |
| Novo Nordisk Investigational Site | Bradford | BD9 6RJ | United Kingdom |
| Novo Nordisk Investigational Site | Bristol | BS2 8ED | United Kingdom |
| Novo Nordisk Investigational Site | Liverpool | L12 2AP | United Kingdom |
| Novo Nordisk Investigational Site | London | WC1N 3JH | United Kingdom |
| Novo Nordisk Investigational Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | rFXIII | Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period | It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product. | Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. | Posted | Mean | Full Range | bleeding episodes per subject per year | For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). |
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| Secondary | Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits | Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube). | Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined. | Posted | Number | percentage (%) of subjects | For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). |
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| Secondary | Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits | Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3). | Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined. | Posted | Mean | Standard Deviation | U/kg | For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). |
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| Secondary | Number of Subjects With rFXIII Antibody Development | Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit) | Full analysis set - Subjects who received at least one dose of trial product. | Posted | Number | participants | For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). |
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Adverse events (AEs) were collected and reported during the entire study period i.e. approximately one year (322 days)
All AEs observed by the investigator or reported spontaneously by the subjects, were recorded by the investigator at each contact with the site (visit or telephone, excluding safety visits, where the subject was not seeing the Investigator or his staff (e.g.visits to the laboratory))
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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 | rFXIII | Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings | 6 | 41 | 25 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Antibody test positive | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Incorrect dose administered | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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Novo Nordisk (NN) reserves the right not to release data until after specified milestones, e.g., finalisation of clinical trial report. This includes the right not to release interim results of clinical trials, as release of such information can invalidate the trial results. At end of trial, one or more manuscripts will be prepared collaboratively between Investigator(s) and NN. NN 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 |
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