Safety of HRX215 After Liver Surgery for Colorectal Cancer
This study is looking at the safety and tolerability of a drug called HRX215 in adults aged 18 to 75 who have had liver surgery (liver resection) for colorectal cancer that has spread to the liver (colorectal carcinoma liver metastases). Researchers want to see if HRX215 is safe and how your body handles it. You would take HRX215 capsules or a placebo (an inactive substance that looks like the drug) twice a day for 28 days. The study will measure any side effects you experience for up to 6 months and check HRX215 levels in your blood for 28 days. The study aims to enroll 80 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing HRX215 to a placebo. It plans to enroll 80 participants.
- What's involved
- You would take HRX215 or placebo twice daily for 28 days. This includes daily visits for the first 7 days, then clinic visits every two weeks for the next two visits, and additional visits at 3 and 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for adverse events for 6 months after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety of HRX215 in Patients After Minor and Major Liver Resection
At a glance
Conditions
Where it's being run
12 sites across 7 statesStudy leadership
- Linda E Greenbaum, MD · STUDY_DIRECTOR · HepaRegeniX GmbH
- Patrick Starlinger, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Adverse Events (AEs) observed6 months
Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.
- HRX215 plasma levels28 days
Levels of drug (HRX215) at selected time intervals after drug administration