Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Liver Cirrhosis

Preoperative presence of clinical ascites

Any other hepatobiliary cancer

BMI >35 kg/m2

Trial design

Treatments tested in this trial

  • HRX215 capsules
  • Placebo capsules

Treatment groups

80 Participants
are divided into 4 treatment groups

Locations

9
France
Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez Lille France
Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB) Villejuif France
Germany
Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie Tübingen Germany
Israel
Rabin Medical Center Petah Tikva Israel

Sponsors and collaborators

HepaRegeniX GmbH

Lead sponsor

Source ClinicalTrials.gov