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
HepaRegeniX GmbH
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.
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 e…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 e…
Interventions
- DrugHRX215 capsules
HRX215 250 mg orally twice daily for a total treatment duration of 28 days
- DrugPlacebo capsules
placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days
Locations (4)
- Mayo ClinicRochester, Minnesota
- Rabin Medical CenterPetah Tikva
- Sheba Medical CenterRamat Gan
- Tel-Aviv Sourasky MCTel Aviv