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Safety of HRX215 in Patients After Minor and Major Liver Resection
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
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
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
About the study
The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases.
The objectives are:
1. to learn about the safety and tolerability of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215. 3. to learn about clinical activity of HRX215
Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.
What is being tested
- HRX215 capsules (drug)
- Placebo capsules (drug)
Sponsor: HepaRegeniX GmbH · Participants: 80 · Started: May 6, 2025
Contact the study team
- Wolfgang Albrecht, PhD NC · Phone: +49 7071 7912809
- Linda Greenbaum, MD · Phone: 484-343-2409
Official record on ClinicalTrials.gov — NCT06638502
Locations in the U.S.
| Maryland | Johns Hopkins Hospital, Baltimore |
| Minnesota | Mayo Clinic, Rochester |
| North Carolina | Duke Cancer Institute, Durham |
| Ohio | Cleveland Clinic, Cleveland |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.