RecruitingPhase 1Phase 2NCT06638502

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


Sponsor

HepaRegeniX GmbH

Enrollment

80 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HRX215 capsules and a drug called Placebo capsules for people with colorectal carcinoma liver metastases and liver resection. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHRX215 capsules

HRX215 250 mg orally twice daily for a total treatment duration of 28 days

DRUGPlacebo capsules

placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days


Locations(12)

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

Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB)

Villejuif, France

Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie

Tübingen, Germany

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel-Aviv Sourasky MC

Tel Aviv, Israel

Hospital Universitario La Paz

Madrid, Spain

South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro

Madrid, Spain

Consorci Hospital General Universitari de València

Valencia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06638502


Related Trials