Sign in

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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitätsklinikum Essen
Coordinator of this site? Confirm its status
EssenGermanyRecruiting
Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie
Coordinator of this site? Confirm its status
TübingenGermanyRecruiting
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Consorci Hospital General Universitari de València
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Coordinator of this site? Confirm its status
LilleFranceRecruiting
Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB)
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting
Rabin Medical Center
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
Sheba medical center
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Tel-Aviv Sourasky MC
Coordinator of this site? Confirm its status
Tel AvivIsraelActive, not recruiting
Johns Hopkins Hospital
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Duke Cancer Institute
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.