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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

2026-05-07

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 (4)

Mayo Clinic

Rochester, Minnesota, United States

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel-Aviv Sourasky MC

Tel Aviv, Israel