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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
Duke Cancer Institute
RECRUITING
Durham
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Other Locations
France
Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez
RECRUITING
Lille
Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB)
RECRUITING
Villejuif
Germany
Universitatsklinikum Essen
NOT_YET_RECRUITING
Essen
Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie
RECRUITING
Tübingen
Israel
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Tel-Aviv Sourasky MC
ACTIVE_NOT_RECRUITING
Tel Aviv
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro
RECRUITING
Madrid
Consorci Hospital General Universitari de València
RECRUITING
Valencia
Contact Information
Primary
Wolfgang Albrecht, PhD NC
info@heparegenix.com
+49 7071 7912809
Backup
Linda Greenbaum, MD
l.greenbaum@heparegenix.com
484-343-2409
Time Frame
Start Date:2025-05-06
Estimated Completion Date:2027-12-31
Participants
Target number of participants:80
Treatments
Experimental: Active treatment minor hepatic resection
Pilot 1: 5 participants will receive HRX215 starting within 1-3 days after minor liver resection for colorectal liver metastases.
Experimental: Active treatment major hepatic resection
Pilot 2: 10 participants will receive HRX215 starting treatment prior to major liver resection for colorectal liver metastases.
Placebo_comparator: Major hepatic resection (Randomized part control arm)
32 participants will receive placebo starting administration prior to major liver resection for colorectal liver metastases
Experimental: Major hepatic resection (Randomized part)
32 participants will receive HRX215 starting administration prior to major liver resection for colorectal liver metastases.