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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001568-22 | EudraCT Number | ||
| U1111-1120-3824 | Other Identifier | WHO |
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Trial screening data did not support the medical hypothesis
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This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFXIII | Experimental |
| |
| Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catridecacog | Drug | Catridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Remission Defined as a Modified Baron Score of 0 | The primary endpoint was the binary variable ("responder" vs. "non-responder") where "responders" were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as "non-responders". | At week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Remission (Clinical and Endoscopic) | Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1). | At Week 8 |
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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 |
|---|---|---|---|---|---|---|
| Rousse | 7002 | Bulgaria | ||||
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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No pre-assignments were given for this trial.
The trial was conducted at 12 sites in 6 countries as follows: Bulgaria (4 sites), Denmark (1 site), Hungary (1 site), Poland (4 sites), Russian Federation (1 site) and Ukraine (1 site).
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| ID | Title | Description |
|---|---|---|
| FG000 | rFXIII | Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses. |
| FG001 | Placebo | Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The demographics and baseline characteristics are presented for the Full analysis set (FAS) which included all randomised and treated subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | rFXIII | Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Endoscopic Remission Defined as a Modified Baron Score of 0 | The primary endpoint was the binary variable ("responder" vs. "non-responder") where "responders" were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as "non-responders". | Full analysis set (FAS) included all randomised and treated subjects. | Number | Subjects | At week 8 |
|
Adverse events reported by the investigator from the first trial-related activity after the subject is exposed to the trial drug until the end of trial visit (Week 10).
Safety analysis set was identical to the FAS which included all randomised and treated subjects.
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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 | Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
The trial was terminated earlier than planned as the hypothesis of a correlation between low levels of FXIII and disease activity of UC could not be confirmed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| C521905 | recombinant factor XIII-A2 |
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|
| placebo | Drug | Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. |
|
| Number of Adverse Events (AEs) | Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period. | Week 0 to 10 |
| Clearance (CL) of rFXIII | The volume of plasma cleared of the drug per unit time. | Samples were collected before and up to 72 hours after the first dose of rFXIII. |
| Maximum Concentration (Cmax) of rFXIII | The peak plasma concentration of the drug after dose administration. | Samples were collected before and up to 72 hours after the first dose of rFXIII. |
| Zagreb |
| 10000 |
| Croatia |
| Herlev | 2730 | Denmark |
| Békéscsaba | H5600 | Hungary |
| Lodz | 90-153 | Poland |
| Nizhny Novgorod | 60316 | Russia |
| Kharkiv | 61000 | Ukraine |
Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses. |
|
|
|
| Secondary | Remission (Clinical and Endoscopic) | Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1). | Full analysis set (FAS) included all randomised and treated subjects. Two subjects in the rFXIII group had no UC-DAI score at any visit, including baseline and they were excluded from the analysis. | Number | Subjects | At Week 8 |
|
|
|
| Secondary | Number of Adverse Events (AEs) | Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period. | Safety analysis set included all randomised and treated subjects. | Number | events | Week 0 to 10 |
|
|
|
| Secondary | Clearance (CL) of rFXIII | The volume of plasma cleared of the drug per unit time. | It was not possible to obtain credible single dose pharmakokinetics (PK) for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles. | Samples were collected before and up to 72 hours after the first dose of rFXIII. |
|
|
| Secondary | Maximum Concentration (Cmax) of rFXIII | The peak plasma concentration of the drug after dose administration. | It was not possible to obtain credible single dose PK for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles. | Samples were collected before and up to 72 hours after the first dose of rFXIII. |
|
|
| 1 |
| 13 |
| 2 |
| 13 |
| EG001 | Placebo | Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses. | 0 | 5 | 2 | 5 |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (16.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
|
Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Novo Nordisk reserves the right to prior review of such publications and to ask for delay of publication of individual site results until after the primary manuscript is accepted for publication.
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Severe adverse events |
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| Moderate adverse events |
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| Mild adverse events |
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| Fatal adverse events |
|