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NCT06638502 · ClinicalTrials.gov registry record · Phase 1
Safety of HRX215 in Patients After Minor and Major Liver Resection
A Phase 1 study of Colorectal Liver Metastases and Liver Resection, sponsored by HepaRegeniX.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06638502: Recruiting Phase 1 study of Colorectal Liver Metastases and Liver Resection, sponsored by HepaRegeniX.
NCT06638502 is a Phase 1 study of Colorectal Liver Metastases and Liver Resection that is actively recruiting participants, run by HepaRegeniX. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06638502, a Phase 1 study of Colorectal Liver Metastases and Liver Resection, is actively recruiting participants, sponsored by HepaRegeniX.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.
Conditions Studied
Interventions
- DRUG Placebo capsules
- DRUG HRX215 capsules
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-05-06 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT06638502 shows while recruiting
NCT06638502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Colorectal Liver Metastases appearing as the primary indexed condition, and to 2 interventions - of which Placebo capsules is the first listed.
NCT06638502 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06638502 about?
NCT06638502 is a clinical study titled "Safety of HRX215 in Patients After Minor and Major Liver Resection". 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 ...
What is the current status of trial NCT06638502?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2025-05-06. Estimated completion is 2027-12-31.
What conditions does trial NCT06638502 study?
This clinical trial studies the following conditions: Colorectal Liver Metastases, Liver Resection.
What interventions are being tested in trial NCT06638502?
The interventions under investigation include: Placebo capsules (DRUG), HRX215 capsules (DRUG).
Who is sponsoring clinical trial NCT06638502?
This trial is sponsored by HepaRegeniX, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06638502 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Liver Metastases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06638502's enrollment target sits among peer trials
25 1496th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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