Safety of HRX215 in Patients After Minor and Major Liver Resection
Recruiting · NCT06638502 · Interventional (participants receive a specific treatment) · Lead sponsor: HepaRegeniX GmbH
View the official record on ClinicalTrials.gov →Interventions studied
HRX215 capsulesPlacebo capsules
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
12 locations listed across 3 US states.
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez - Lille, France
- Hospital Universitario La Paz - Madrid, Spain
- South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro - Madrid, Spain
- Rabin Medical Center - Petah Tikva, Israel
- Sheba Medical Center - Ramat Gan, Israel
- Tel-Aviv Sourasky MC - Tel Aviv, Israel
- Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie - Tübingen, Germany
- Consorci Hospital General Universitari de València - Valencia, Spain
- Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB) - Villejuif, France