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Safety of HRX215 in Patients After Minor and Major Liver Resection

ConditionsLiver ResectionColorectal Carcinoma Liver Metastases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHepaRegeniX GmbH

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Liver Cirrhosis

Preoperative presence of clinical ascites

Any other hepatobiliary cancer

BMI >35 kg/m2

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRX215 capsules

    Drug

    HRX215 250 mg orally twice daily for a total treatment duration of 28 days

  • Placebo capsules

    Drug

    placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Active treatment minor hepatic resectionExperimental treatment 1 intervention
Group B: Active treatment major hepatic resectionExperimental treatment 1 intervention
Group C: Major hepatic resection (Randomized part control arm)Placebo comparator 1 intervention
Group D: Major hepatic resection (Randomized part)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AEs) observed

Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.

Time frame
6 months
2

HRX215 plasma levels

Levels of drug (HRX215) at selected time intervals after drug administration

Time frame
28 days

Secondary outcomes

1

Efficacy (major liver resection)

Liver volume and increase in liver volume at postoperative day 7 vs. postoperative day 1

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HepaRegeniX GmbH

Lead sponsor

Source ClinicalTrials.gov
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