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Safety of HRX215 in Patients After Minor and Major Liver Resection

NCT06638502 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Liver Resection
  • Colorectal Carcinoma Liver Metastases

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

Sponsors & Collaborators

  • HepaRegeniX GmbH

    lead INDUSTRY

Principal Investigators

  • Linda E Greenbaum, MD · HepaRegeniX GmbH

  • Patrick Starlinger, MD, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638502 on ClinicalTrials.gov