RECRUITING

Safety of HRX215 in Patients After Minor and Major Liver Resection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-05-06
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06638502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. For the pilot phase less extended resections (remnant liver volume \>69%) are required)
  3. 3. Percentage of Remnant Liver Volume (RLV) 28%-50% (randomized part of the study)
  1. 1. Liver Cirrhosis
  2. 2. Preoperative presence of clinical ascites
  3. 3. Any other liver cancer
  4. 4. BMI \>35 kg/m2
  5. 5. ASA Score\>4
  6. 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. 7. Incomplete liver metastasis resection -

Contacts and Locations

Study Contact

Wolfgang Albrecht, Doctorate of Natural Sciences
CONTACT
49 7071 7912809
info@heparegenix.com
Linda Greenbaum, M.D.
CONTACT
484-343-2409
l.greenbaum@heparegenix.com

Principal Investigator

Linda E Greenbaum, M.D.
STUDY_DIRECTOR
HepaRegeniX GmbH
Patrick Starlinger, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: HepaRegeniX GmbH

  • Linda E Greenbaum, M.D., STUDY_DIRECTOR, HepaRegeniX GmbH
  • Patrick Starlinger, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Colorectal Liver Metastases
  • Liver Resection