Safety of HRX215 in Patients After Minor and Major Liver Resection
Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases
HepaRegeniX GmbH
80 participants
May 6, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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
Exclusion Criteria6
- Liver Cirrhosis
- Preoperative presence of clinical ascites
- Any other hepatobiliary cancer
- BMI >35 kg/m2
- ASA Score >4
- Peritoneal carcinomatosis
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Interventions
HRX215 250 mg orally twice daily for a total treatment duration of 28 days
placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06638502