Safety of HRX215 in Patients After Minor and Major Liver Resection
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Liver Resection, Colorectal Carcinoma Liver Metastases
In brief
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.
Key facts
- Study ID
- NCT06638502
- Run by
- HepaRegeniX GmbH
- People needed
- 80
- Starts
- 2025-05-06
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Liver Cirrhosis
- Preoperative presence of clinical ascites
- Any other hepatobiliary cancer
- BMI >35 kg/m2
- ASA Score >4
- Peritoneal carcinomatosis
- Further exclusion criteria apply
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez — Lille, France (enrolling)
- Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB) — Villejuif, France (enrolling)
- Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie — Tübingen, Germany (enrolling)
- Rabin Medical Center — Petah Tikva, Israel (enrolling)
- Sheba Medical Center — Ramat Gan, Israel (enrolling)
- Tel-Aviv Sourasky MC — Tel Aviv, Israel (enrolling)
- Hospital Universitario La Paz — Madrid, Spain (enrolling)
- South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro — Madrid, Spain (enrolling)
- Consorci Hospital General Universitari de València — Valencia, Spain (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.