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Safety of HRX215 in Patients After Minor and Major Liver Resection

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllHepaRegeniX GmbH
NCT06638502 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • HRX215 capsules
  • Placebo capsules
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Where

14 sites
Johns Hopkins Hospital
Baltimore, United States
Mayo Clinic
Rochester, United States
Duke Cancer Institute
Durham, United States
Cleveland Clinic
Cleveland, United States
Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez
Lille, France
Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB)
Villejuif, France
Universitatsklinikum Essen
Essen, Germany
Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie
Tübingen, Germany

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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