Double-blind, randomized, placebo-controlled, study to evaluate the safety and efficacy of HRX215 in participants after major hepatectomy, preceded by two open pilot parts in participants after minor and after major hepatectomy due to colon carcinoma metastases

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523630-59-00

Enrollment

Registered

2026-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon carcinoma metastases

Brief summary

Incidence, severity, and relatedness of AEs/SAEs, Changes from baseline in vital signs and physical examination findings, Changes from baseline in clinical laboratory parameters (hematology,blood, glucose) at prespecified time points, Plasma PK of HRX215 (Cmax, Tmax, AUC etc.); comparison with Phase 1 healthy-subject PK data

Detailed description

Establishment of Efficacy (main study part 3): • Liver volume on POD1 and POD7 and increase in liver volume at POD7 vs. POD1 (absolute change from POD1 CT)

Interventions

DRUGWhite opaque capsules

DRUGsize 1

DRUGHRX215

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence, severity, and relatedness of AEs/SAEs, Changes from baseline in vital signs and physical examination findings, Changes from baseline in clinical laboratory parameters (hematology,blood, glucose) at prespecified time points, Plasma PK of HRX215 (Cmax, Tmax, AUC etc.); comparison with Phase 1 healthy-subject PK data	—

Secondary

Measure	Time frame
Establishment of Efficacy (main study part 3): • Liver volume on POD1 and POD7 and increase in liver volume at POD7 vs. POD1 (absolute change from POD1 CT)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 21, 2026