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Safety of HRX215 in Patients After Minor and Major Liver Resection
Sponsor: HepaRegeniX GmbH
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
HRX215 capsules
HRX215 250 mg orally twice daily for a total treatment duration of 28 days
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