Safety of HRX215 in Patients After Minor and Major Liver Resection
Purpose
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
Conditions
- Colorectal Liver Metastases
- Liver Resection
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Stable male and female patients between 18 and 75 years within 1-3 days after extended resection of the right or left liver lobe due to metastases of a colon carcinoma, but otherwise normal liver parenchyma proven by histopathology assessment of a liver biopsy within 3 months before surgery and liver functional parameters. 2. For the pilot phase less extended resections (remnant liver volume >69%) are required) 3. Percentage of Remnant Liver Volume (RLV) 28%-50% (randomized part of the study) -
Exclusion Criteria
- Liver Cirrhosis 2. Preoperative presence of clinical ascites 3. Any other liver cancer 4. BMI >35 kg/m2 5. ASA Score>4 6. CC Score >0: all patients with pre-operatively or intra-operatively diagnosed peritoneal carcinosis or other pre-op or intra-op findings which would deem the patient to be unresectable, are excluded. 7. Incomplete liver metastasis resection -
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active treatment minor hepatic resection |
5 participants will receive HRX215 250 mg twice daily orally within 1-3 days after minor (<=31%) liver resection for colorectal liver metastases for 28 days. |
|
|
Active Comparator Active treatment arm major hepatic resection |
10 participants will receive HRX215 250 mg twice daily orally within 1-3 days after major (50-72%) liver resection for colorectal liver metastases for 28 days. |
|
|
Placebo Comparator placebo arm major hepatic resection |
10 participants will receive placebo capsules with matching appearance to HRX215 twice daily orally within 1-3 days after major (50-72%) liver resection for colorectal liver metastases for 28 days |
|
Recruiting Locations
Rochester, Minnesota 55905
More Details
- Status
- Recruiting
- Sponsor
- HepaRegeniX GmbH
Detailed Description
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.