Clinical trial NCT06638502: Safety of HRX215 in Patients After Minor and Major Liver Resection
Official title: Double Blind, Randomized, Placebo Controlled, Study to Evaluate the Safety of HRX215 in Patients Post Major Hepatectomy, Preceded by an Open Pilot Phase in Patients Post Minor Hepatectomy Due to Metastases of a Colon Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Colorectal Liver Metastases
Liver Resection
Lead sponsor: HepaRegeniX GmbH
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: Inclusion Criteria:

1. 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 \&amp;gt;69%) are required)
3. Percentage of Remnant Liver Volume (RLV) 28%-50% (randomized part of the study)

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Exclusion Criteria:

1. Liver Cirrhosis
2. Preoperative presence of clinical ascites
3. Any other liver cancer
4. BMI \&gt;35 kg/m2
5. ASA Score\&gt;4
6. CC Score \&gt;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 -

Primary outcomes:
measure: • Adverse Events (AEs) observed.
timeFrame: 28 days
Secondary outcomes:
measure: Pharmacokinetic Plasma Analysis
timeFrame: 28 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: HepaRegeniX GmbH
name: Linda E Greenbaum, M.D.
role: STUDY_DIRECTOR
affiliation: Mayo Clinic
name: Patrick Starlinger, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: