NCT06638502

Safety of HRX215 in Patients After Minor and Major Liver Resection

Double Blind, Randomized, Placebo Controlled, Study to Evaluate the Safety of HRX215 in Patients Post Major Hepatectomy, Preceded by an Open Pilot Phase in Patients Post Minor Hepatectomy Due to Metastases of a Colon Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: HepaRegeniX GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if HRX215 is safe and tolerable in adults who have undergone surgical removal of metastatic tumor(s) due to colorectal carcinoma in the liver. The main question it aims to answer are: 1. to learn about the safety of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215 . Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to see what medical problems participants have when taking HRX215. Participants will: Take HRX215 or a placebo twice a day for 28 days Daily visits for 7 days for checkups and tests which may either be in the hospital or outpatient after 3 days. Clinic visits every two weeks for the next two visits. The visit at two weeks may be a home visit or clinic visit. Additional clinic visits 3 months and 6 months after the start of treatment

Detailed description

The study is designed to evaluate primarily the safety of HRX215, first after minor liver resection and, when safety is established, in those patients after major liver resection. Participants will start treatment within 1-3 days after liver resection and will receive 28 day treatment with HRX215 twice daily or placebo with follow up visits 3 and 6 months after completion of treatment. The pharmacokinetics will be compared with the results of the phase I studies, whereas efficacy will be evaluated only descriptively. Secondary objectives will include evaluation of differences in liver volume recovery postoperatively and clinical outcomes including days in the ICU and 90 day mortality in participants who receive treatment with HRX215 vs. placebo.

Conditions

• Colorectal Liver Metastases
• Liver Resection

Interventions

Type	Name	Description
DRUG	HRX215 capsules	HRX215 capsules 250 mg orally twice daily
DRUG	Placebo capsules	placebo capsules matching appearance of HRX215

Timeline

• Start date: 2025-05-06
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2024-10-15
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study