NCT06638502 Safety of HRX215 in Patients After Minor and Major Liver Resection
| NCT ID | NCT06638502 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | HepaRegeniX GmbH |
| Condition | Liver Resection |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-05-06 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Further inclusion criteria apply Exclusion Criteria: * Liver Cirrhosis * Preoperative presence of clinical ascites * Any other hepatobiliary cancer * BMI \>35 kg/m2 * ASA Score \>4 * Peritoneal carcinomatosis Further exclusion criteria apply
Contact & Investigator
Linda E Greenbaum, MD
STUDY DIRECTOR
HepaRegeniX GmbH
Frequently Asked Questions
Who can join the NCT06638502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Liver Resection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06638502 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06638502 currently recruiting?
Yes, NCT06638502 is actively recruiting participants. Contact the research team at info@heparegenix.com for enrollment information.
Where is the NCT06638502 trial being conducted?
This trial is being conducted at Baltimore, United States, Rochester, United States, Durham, United States, Cleveland, United States and 10 additional locations.
Who is sponsoring the NCT06638502 clinical trial?
NCT06638502 is sponsored by HepaRegeniX GmbH. The principal investigator is Linda E Greenbaum, MD at HepaRegeniX GmbH. The trial plans to enroll 80 participants.