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
Additional locations may be listed on ClinicalTrials.gov for NCT06638502.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Active
Name Not Available
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.
Lead OrganizationHepaRegeniX GmbH
Principal InvestigatorPatrick P Starlinger
