NCT06638502RecruitingPhase 1/2
Safety of HRX215 in Patients After Minor and Major Liver Resection
Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 9 Oct 2024
- Start date
- 6 May 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- HepaRegeniX GmbH
- NCT number
- NCT06638502
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- From 6 May 2025 to the primary completion date, 31 Jul 2027
- 14 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any other hepatobiliary cancer
Other
- Liver Cirrhosis
- Preoperative presence of clinical ascites
- BMI \>35 kg/m2
- ASA Score \>4
- Peritoneal carcinomatosis
- Further exclusion criteria apply
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie Coordinator of this site? Confirm its status | Tübingen | Germany | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Consorci Hospital General Universitari de València Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB) Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel-Aviv Sourasky MC Coordinator of this site? Confirm its status | Tel Aviv | Israel | Active, not recruiting |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.