Liver ResectionPhase 1/2NCT06638502
Safety of HRX215 in Patients After Minor and Major Liver Resection
A Phase 1/2 study testing HRX215 capsules in people with Liver Resection and Colorectal Carcinoma Liver Metastases, run by HepaRegeniX GmbH at 14 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Resection, Colorectal Carcinoma Liver Metastases
- What is being tested?
- HRX215 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 6 May 2025to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Liver Cirrhosis
- Preoperative presence of clinical ascites
- Any other hepatobiliary cancer
- BMI >35 kg/m2
- ASA Score >4
- Peritoneal carcinomatosis
- Further exclusion criteria apply
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
United States4 sites, 4 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Christopher Shubert, MD, 410-502-9207, Christopher.shubert@jhu.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Frederico Aucejo, MD, 216-444-0537, aucejof@ccf.org
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Michael Lidsky, MD, 919-613-1474, michael.lidsky@duke.edu
Michael Lidsky, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Patrick Starlinger, M.D Ph.D.
Israel3 sites, 2 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Eran Sadot, MD, PhD, Professor, +972 54 2222021, EranSa3@clalit.org.il
Eran Sadot, M, PhD, Professor
- Recruiting
Sheba Medical Center
Ramat Gan
Niv Pencovich, MD, PhD, Professor, +972 52 7360036, Niv.Pencovich@sheba.health.gov.il
Niv Pencovich, MD, PhD, Professor
- Active, not recruiting
Tel-Aviv Sourasky MC
Tel Aviv
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid
Constantino Fondevila Campo, MD, PhD, +34 91 207 1667, constantino.fondevila@salud.madrid.org
- Recruiting
South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro
Madrid
Riccardo Caruso, MD, PhD, +34 917 56 78 00, ricaruso2@gmail.com
Riccardo Caruso, MD, PhD
- Recruiting
Consorci Hospital General Universitari de València
Valencia
José Mir, MD, PhD, +34 96-386-29-93, jomirla@gmail.com
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez
Lille
Stephanie Truant, MD. PhD, +33 3-2044-4260, Stephanie.TRUANT@chu-lille.fr
Stephanie Truant, MD, PhD
- Recruiting
Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB)
Villejuif
René Adam, MD, PhD, +33 1 45 59 30 49, rene.adam@pbr.aphp.fr
Germany2 sites, 2 recruiting
- Recruiting
Universitatsklinikum Essen
Essen
Ulf Neumann, MD, PhD, +49 201 723 1130, ulf.neumann@uk-essen.de
Ulf Neumann, MD, PhD
- Recruiting
Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie
Tübingen
Silvio Nadalin, MD. PhD, +49 7071-29-83387, silvio.nadalin@med.uni-tuebingen.de
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases
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:
- to learn about the safety and tolerability of HRX215
- to learn about how the body absorbs, distributes, and gets rid of HRX215.
- 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.
Read the detailed description
The study is designed to evaluate primarily the safety of HRX215, first after minor liver resection and subsequently in participants after major liver resection. Participants undergoing major liver resection will start treatment shortly before liver resection surgery and will receive 28 days of treatment with HRX215 or placebo twice daily with follow up visits at 3 and 6 months.
Participants will take HRX215 or a placebo twice a day for 28 days. Daily visits for the first 7 days of treatment 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. Additional clinic visits 3 months and 6 months after the start of treatment.
The pharmacokinetics will be compared with the results of the phase I studies in healthy subjects.
Secondary objectives will include evaluation of liver volume and liver volume increase postoperatively.
- Being tested
- HRX215 capsules, Placebo capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRX215 capsulesDrug
HRX215 250 mg orally twice daily for a total treatment duration of 28 days
Placebo capsulesDrug
placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days
| Study group | Role | What they receive |
|---|---|---|
| Active treatment minor hepatic resection | Experimental | Pilot 1: 5 participants will receive HRX215 starting within 1-3 days after minor liver resection for colorectal liver metastases. Receives: Drug: HRX215 capsules |
| Active treatment major hepatic resection | Experimental | Pilot 2: 10 participants will receive HRX215 starting treatment prior to major liver resection for colorectal liver metastases. Receives: Drug: HRX215 capsules |
| Major hepatic resection (Randomized part control arm) | Placebo comparator | 32 participants will receive placebo starting administration prior to major liver resection for colorectal liver metastases Receives: Drug: Placebo capsules |
| Major hepatic resection (Randomized part) | Experimental | 32 participants will receive HRX215 starting administration prior to major liver resection for colorectal liver metastases. Receives: Drug: HRX215 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) observed
Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.
Measured: 6 months
HRX215 plasma levels
Levels of drug (HRX215) at selected time intervals after drug administration
Measured: 28 days
Secondary outcomes (1)
Efficacy (major liver resection)
Liver volume and increase in liver volume at postoperative day 7 vs. postoperative day 1
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start6 May 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HepaRegeniX GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda E Greenbaum, MD, Study director, HepaRegeniX GmbHPatrick Starlinger, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638502
- Sponsor's protocol ID
- HRX215-CR03-LR01
- Status last verified
- Jul 2026
- First submitted
- 9 Oct 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases
- ClinicalTrials.gov ID
- NCT06638502
- Acronym / sponsor ID
- HRX215-CR03-LR01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HepaRegeniX GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to learn about the safety and tolerability of HRX215
- to learn about how the body absorbs, distributes, and gets rid of HRX215.
- 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.
Detailed description
The study is designed to evaluate primarily the safety of HRX215, first after minor liver resection and subsequently in participants after major liver resection. Participants undergoing major liver resection will start treatment shortly before liver resection surgery and will receive 28 days of treatment with HRX215 or placebo twice daily with follow up visits at 3 and 6 months.
Participants will take HRX215 or a placebo twice a day for 28 days. Daily visits for the first 7 days of treatment 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. Additional clinic visits 3 months and 6 months after the start of treatment.
The pharmacokinetics will be compared with the results of the phase I studies in healthy subjects.
Secondary objectives will include evaluation of liver volume and liver volume increase postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active treatment minor hepatic resection | Experimental | Drug: HRX215 capsulesPilot 1: 5 participants will receive HRX215 starting within 1-3 days after minor liver resection for colorectal liver metastases. |
| Active treatment major hepatic resection | Experimental | Drug: HRX215 capsulesPilot 2: 10 participants will receive HRX215 starting treatment prior to major liver resection for colorectal liver metastases. |
| Major hepatic resection (Randomized part control arm) | Placebo comparator | Drug: Placebo capsules32 participants will receive placebo starting administration prior to major liver resection for colorectal liver metastases |
| Major hepatic resection (Randomized part) | Experimental | Drug: HRX215 capsules32 participants will receive HRX215 starting administration prior to major liver resection for colorectal liver metastases. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Liver Cirrhosis
- Preoperative presence of clinical ascites
- Any other hepatobiliary cancer
- BMI >35 kg/m2
- ASA Score >4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRX215 capsulesHRX215 250 mg orally twice daily for a total treatment duration of 28 days | Drug | Active treatment major hepatic resection, Active treatment minor hepatic resection, Major hepatic resection (Randomized part) |
| Placebo capsulesplacebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days | Drug | Major hepatic resection (Randomized part control arm) |
Primary outcome
Adverse Events (AEs) observed
Time frame: 6 months
Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.
HRX215 plasma levels
Time frame: 28 days
Levels of drug (HRX215) at selected time intervals after drug administration
1 secondary outcome
Efficacy (major liver resection)
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda E Greenbaum, MD study director
HepaRegeniX GmbH
Patrick Starlinger, MD, PhD principal investigator
Mayo Clinic
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRX215 capsules in people with Liver Resection and Colorectal Carcinoma Liver Metastases, run by HepaRegeniX GmbH at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Israel, Spain, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Albrecht, PhD NC (+49 7071 7912809, info@heparegenix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) observed (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.