A Phase 2 interventional study of catridecacog and placebo in Inflammation and Ulcerative Colitis, sponsored by Novo Nordisk A/S. Terminated at 7 sites in 7 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-10-02.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
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).
1,073 studies on the registry are indexed under Colitis; 133 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →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.
Exclusion Criteria:
Drug: catridecacog
Drug: placebo
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
Also known as: recombinant factor XIII
Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.
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".
Time frame: At week 8
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).
Time frame: At Week 8
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.
Time frame: Week 0 to 10
Clearance (CL) of rFXIII
The volume of plasma cleared of the drug per unit time.
Time frame: 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.
Time frame: Samples were collected before and up to 72 hours after the first dose of rFXIII.
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).
| Milestone | rFXIII | Placebo |
|---|---|---|
| Started | 14 | 6 |
| Exposed | 13 | 5 |
| Completers (with baron score at week 8) | 6 | 3 |
| Completed | 6 | 4 |
| Not completed | 8 | 2 |
| Withdrew: Withdrawal criteria | 2 | 1 |
| Withdrew: Unclassified | 6 | 1 |
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".
| Subjects | rFXIII | Placebo |
|---|---|---|
| Endoscopic Remission Defined as a Modified Baron Score of 0 | 1 | 1 |
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).
| Subjects | rFXIII | Placebo |
|---|---|---|
| Remission (Clinical and Endoscopic) | 0 | 0 |
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.
| events | rFXIII | Placebo |
|---|---|---|
| Adverse events | 7 | 4 |
| Serious adverse events | 1 | 0 |
| Severe adverse events | 1 | 0 |
| Moderate adverse events | 0 | 2 |
| Mild adverse events | 6 | 2 |
| Fatal adverse events | 0 | 0 |
The volume of plasma cleared of the drug per unit time.
No measurements were reported for this outcome.
The peak plasma concentration of the drug after dose administration.
No measurements were reported for this outcome.
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rFXIII | — | 1/13 (7.7%) | 2/13 (15.4%) |
| Placebo | — | 0/5 (0%) | 2/5 (40%) |
| Event | rFXIII | Placebo |
|---|---|---|
| Colitis ulcerativeGastrointestinal disorders | 1/13 | 0/5 |
| Event | rFXIII | Placebo |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/13 | 1/5 |
| Colitis ulcerativeGastrointestinal disorders | 0/13 | 1/5 |
| FatigueGeneral disorders | 0/13 | 1/5 |
| BronchitisInfections and infestations | 0/13 | 1/5 |
| AstheniaGeneral disorders | 1/13 | 0/5 |
| Oedema peripheralGeneral disorders | 1/13 | 0/5 |
| Urinary tract infectionInfections and infestations | 1/13 | 0/5 |
| Blood creatinine increasedInvestigations | 1/13 | 0/5 |
| HypokalaemiaMetabolism and nutrition disorders | 1/13 | 0/5 |
| Bone painMusculoskeletal and connective tissue disorders | 1/13 | 0/5 |
The demographics and baseline characteristics are presented for the Full analysis set (FAS) which included all randomised and treated subjects.
| Age, Continuous(years) | rFXIII | Placebo | Total |
|---|---|---|---|
| Mean | 36.9 ± 10.6 | 45.0 ± 15.4 | 39.2 ± 12.2 |
| Sex: Female, Male(Participants) | rFXIII | Placebo | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 8 | 1 | 9 |
| Race/Ethnicity, Customized(participants) | rFXIII | Placebo | Total |
|---|---|---|---|
| Whites | 13 | 5 | 18 |
| Body Mass Index(kg/m^2) | rFXIII | Placebo | Total |
|---|---|---|---|
| Mean | 24.5 ± 3.2 | 25.6 ± 5.8 | 24.8 ± 3.9 |
This study is terminated, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S