Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as recombinant factor XIII
catridecacog · 11 trials · 5 indications
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.
A measure of the exposure. Blood samples for the PK assessment were drawn pre-dose and up to 30 days after dosing. The PK of FXIII in children was assessed after a single i.v. dose of rFXIII 35 IU/kg.
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Trial AEs (serious) included any event such as death, life-threatening experience, in-subject hospitalisation, significant disability/ congential anomaly experienced from the trial product.
It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product.
Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.
| Arm | Type | Description |
|---|---|---|
| rFXIII 35 IU/kg | EXPERIMENTAL | - |
| recombinant factor XIII | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| rFXIII | EXPERIMENTAL | - |
| FXIII17.5IU/Kg | EXPERIMENTAL | Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute. |
| FXIII35IU/Kg | EXPERIMENTAL | Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute. |
| Placebo | PLACEBO_COMPARATOR | Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute. |
| B | EXPERIMENTAL | - |
| C | PLACEBO_COMPARATOR | - |
| D | PLACEBO_COMPARATOR | - |
| Trial part 1 | EXPERIMENTAL | - |
| Trial part 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| catridecacog | DRUG | Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg body weight every 4th week |
| placebo | DRUG | Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute |
| recombinant factor XIII | DRUG | Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv. |
Inclusion Criteria: * Completed participation in trial F13CD-3760 (NCT01230021) 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 oth...
Catridecacog is being developed for congenital and acquired bleeding disorders, including congenital factor XIII A-subunit deficiency. It is a recombinant factor XIII product studied as replacement therapy to prevent bleeding in patients with factor XIII deficiency and in surgical settings such as cardiac surgery requiring cardiopulmonary bypass.
Catridecacog targets the F13A1 protein, also known as the factor XIII A-subunit. It is an exogenous protein that provides the A-subunit of factor XIII, which is needed for fibrin cross-linking and clot stabilization. In patients with factor XIII A-subunit deficiency, this replacement supports normal clot formation.
Catridecacog is being developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical trials evaluating the drug in bleeding disorders and related surgical settings.
Catridecacog is in Phase 2 development. It has not been approved by the FDA and remains an investigational therapy. Clinical trials completed to date include Phase 1 and Phase 3 studies, but the overall development program is at the Phase 2 stage.
Catridecacog has been studied in several completed trials, including NCT02239146 in patients undergoing first-time myocardial revascularization requiring cardiopulmonary bypass, NCT01848002 and NCT01847989 in healthy volunteers, and NCT01253811 in pediatric subjects with congenital factor XIII A-subunit deficiency.