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RECRUITING
NCT06638502
PHASE1/PHASE2

Safety of HRX215 in Patients After Minor and Major Liver Resection

Sponsor: HepaRegeniX GmbH

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-05-06

Completion Date

2027-12-31

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

HRX215 capsules

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

DRUG

Placebo 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