CARPO

A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS

Ensayo de CalciMedica, Inc. en Acute Pancreatitis · Systemic Inflammatory Response Syndrome (del registro, en inglés).

Fase: Fase 2
Estado: Completado
Participantes: 216
Centros: 37
Fin del objetivo primario: may 2024

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2021.

Qué mide

Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship (from start of first infusion of study drug (SFISD) through day 30) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroApproximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection necessitating continued hospitalization.

Más ensayos de CALC

Ensayo	Fase	Estado	Lectura de resultados
Auxora · KOURAGE	Fase 2	Interrumpido	abr 2026 (real)
Auxora · CARDEA-Plus	Fase 2	Retirado antes de empezar	jul 2022 (prevista, ya pasada: sin actualizar en el registro)
CM4620-IE	Fase 2	Interrumpido	dic 2021 (real)
Auxora	Fase 2	Completado	jun 2021 (real)
CM4620-IE	Fase 2	Completado	mar 2019 (real)
CM4620 Injectable Emulsion	Fase 2	Completado	feb 2019 (real)

Todos los de CALC, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04681066), actualizada en ago 2026.