Clinical Research Directory

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 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

Official title: 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

Key Details

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Interventions

Locations (1)