Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational recombinant factor XIII product being developed for congenital bleeding disorder, specifically congenital factor XIII deficiency, and acquired bleeding disorder. It is a small molecule in the hematology therapeutic area, currently in Phase 2 clinical development by Novo Nordisk.
Catridecacog targets factor XIII, a key protein in the blood clotting cascade. It is a recombinant form of factor XIII designed to replace or supplement the deficient enzyme in patients with congenital factor XIII deficiency, thereby helping to stabilize blood clots and prevent bleeding episodes.
Catridecacog is being developed by Novo Nordisk A/S, a global healthcare company traded under the ticker NVO. The drug is currently in Phase 2 clinical development for congenital and acquired bleeding disorders.
Catridecacog is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The development program includes eight completed trials, with no active trials currently ongoing, and a total enrollment of 546 participants across those studies.
Catridecacog has been studied in eight completed clinical trials. Notable trials include NCT00056589, a Phase 1 study in patients with congenital factor XIII deficiency, and NCT01082406, NCT01847989, and NCT01848002, which are Phase 1 studies in healthy volunteers. All trials are completed.
Catridecacog is a recombinant factor XIII product, meaning it is a laboratory-made version of the naturally occurring factor XIII protein. It is being developed to treat congenital factor XIII deficiency, a rare bleeding disorder, by providing the missing clotting factor.