Safety of HRX215 in Patients After Minor and Major Liver Resection
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHepaRegeniX GmbH
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Liver Cirrhosis
Preoperative presence of clinical ascites
Any other hepatobiliary cancer
BMI >35 kg/m2
Trial design
Treatments tested in this trial
- HRX215 capsules
- Placebo capsules
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov