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USClinicalTrials.govClinical trialPhase 1/2Recruiting

Safety of HRX215 in Patients After Minor and Major Liver Resection

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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
Sep 14, 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
Indexed under
Liver Cancer