Safety of HRX215 in Patients After Minor and Major Liver Resection

Official record

Identifier

NCT06638502

Recruiting locations

countries

United StatesFranceGermanyIsraelSpain

Interventions studied

HRX215 capsulesPlacebo capsules

Lead sponsor

HepaRegeniX GmbH

Target enrolment

80 participants

Study type

INTERVENTIONAL

Phase

Phase 1/2

Status

Recruiting

First posted

Oct 15, 2024

Last updated on the registry

Jul 30, 2026

Age

18 Years – 75 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Participants with liver metastases originating from colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases
* Part 1 only: stable participants within 1-3 days after minor liver resection, normal non-tumor liver parenchyma
* Part 2 and 3 only: Major liver resection.
* Low estimated risk for post-hepatectomy liver failure PHLF

Further inclusion criteria apply

Exclusion Criteria:

* Liver Cirrhosis
* Preoperative presence of clinical ascites
* Any other hepatobiliary cancer
* BMI \>35 kg/m2
* ASA Score \>4
* Peritoneal carcinomatosis

Further exclusion criteria apply