Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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