Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06638502

Safety of HRX215 in Patients After Minor and Major Liver Resection

Led by HepaRegeniX GmbH · Updated on 2026-05-07

80

Participants Needed

4

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Safety of HRX215 in Patients After Minor and Major Liver Resection

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with liver metastases from colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases
  • Stable participants within 1-3 days after minor liver resection with normal non-tumor liver parenchyma (Part 1 only)
  • Participants undergoing major liver resection (Parts 2 and 3 only)
  • Low estimated risk for post-hepatectomy liver failure (PHLF)
  • Further inclusion criteria apply
Not Eligible

You will not qualify if you...

  • Liver cirrhosis
  • Presence of clinical ascites before surgery
  • Any other hepatobiliary cancer
  • Body mass index (BMI) greater than 35 kg/m2
  • ASA Score greater than 4
  • Peritoneal carcinomatosis
  • Further exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

2

Rabin Medical Center

Petah Tikva, Israel

Not Yet Recruiting

3

Sheba Medical Center

Ramat Gan, Israel

Actively Recruiting

4

Tel-Aviv Sourasky MC

Tel Aviv, Israel

Not Yet Recruiting

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Research Team

W

Wolfgang Albrecht, PhD NC

CONTACT

L

Linda Greenbaum, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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