The study is designed to evaluate primarily the safety of HRX215, first after minor liver resection and subsequently in participants after major liver resection. Participants undergoing major liver resection will start treatment shortly before liver resection surgery and will receive 28 days of treatment with HRX215 or placebo twice daily with follow up visits at 3 and 6 months.
Participants will take HRX215 or a placebo twice a day for 28 days. Daily visits for the first 7 days of treatment 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. Additional clinic visits 3 months and 6 months after the start of treatment.
The pharmacokinetics will be compared with the results of the phase I studies in healthy subjects.
Secondary objectives will include evaluation of liver volume and liver volume increase postoperatively.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with liver metastases originating from colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases
Part 1 only: stable participants within 1-3 days after minor liver resection, normal non-tumor liver parenchyma
Part 2 and 3 only: Major liver resection.
Low estimated risk for post-hepatectomy liver failure PHLF
