Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-09 @ 8:14 AM
Study NCT ID:
NCT06638502
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of HRX215 in Patients After Minor and Major Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-10', 'studyFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Adverse Events (AEs) observed.', 'timeFrame': '28 days', 'description': '* Adverse Events (AEs) observed\n* Clinical laboratory investigation including hematology, blood glucose, HbA1c, serum chemistry: pre-treatment, after 14 and 28 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic Plasma Analysis', 'timeFrame': '28 days', 'description': 'Levels of drug (HRX215) at selected time intervals after drug administration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Liver Metastases', 'Liver Resection']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question it aims to answer are:\n\n1. to learn about the safety of HRX215\n2. 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.\n\nParticipants will:\n\nTake 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', 'detailedDescription': 'The study is designed to evaluate primarily the safety of HRX215, first after minor liver resection and, when safety is established, in those patients after major liver resection. Participants will start treatment within 1-3 days after liver resection and will receive 28 day treatment with HRX215 twice daily or placebo with follow up visits 3 and 6 months after completion of treatment.\n\nThe pharmacokinetics will be compared with the results of the phase I studies, whereas efficacy will be evaluated only descriptively. Secondary objectives will include evaluation of differences in liver volume recovery postoperatively and clinical outcomes including days in the ICU and 90 day mortality in participants who receive treatment with HRX215 vs. placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stable male and female patients between 18 and 75 years within 1-3 days after extended resection of the right or left liver lobe due to metastases of a colon carcinoma, but otherwise normal liver parenchyma proven by histopathology assessment of a liver biopsy within 3 months before surgery and liver functional parameters.\n2. For the pilot phase less extended resections (remnant liver volume \\&gt;69%) are required)\n3. Percentage of Remnant Liver Volume (RLV) 28%-50% (randomized part of the study)\n\n \\-\n\nExclusion Criteria:\n\n1. Liver Cirrhosis\n2. Preoperative presence of clinical ascites\n3. Any other liver cancer\n4. BMI \\>35 kg/m2\n5. ASA Score\\>4\n6. CC Score \\>0: all patients with pre-operatively or intra-operatively diagnosed peritoneal carcinosis or other pre-op or intra-op findings which would deem the patient to be unresectable, are excluded.\n7. Incomplete liver metastasis resection -'}, 'identificationModule': {'nctId': 'NCT06638502', 'briefTitle': 'Safety of HRX215 in Patients After Minor and Major Liver Resection', 'organization': {'class': 'INDUSTRY', 'fullName': 'HepaRegeniX GmbH'}, 'officialTitle': 'Double Blind, Randomized, Placebo Controlled, Study to Evaluate the Safety of HRX215 in Patients Post Major Hepatectomy, Preceded by an Open Pilot Phase in Patients Post Minor Hepatectomy Due to Metastases of a Colon Carcinoma', 'orgStudyIdInfo': {'id': 'HRX215-CR03-LR01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active treatment minor hepatic resection', 'description': '5 participants will receive HRX215 250 mg twice daily orally within 1-3 days after minor (\\<=31%) liver resection for colorectal liver metastases for 28 days.', 'interventionNames': ['Drug: HRX215 capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active treatment arm major hepatic resection', 'description': '10 participants will receive HRX215 250 mg twice daily orally within 1-3 days after major (50-72%) liver resection for colorectal liver metastases for 28 days.', 'interventionNames': ['Drug: HRX215 capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo arm major hepatic resection', 'description': '10 participants will receive placebo capsules with matching appearance to HRX215 twice daily orally within 1-3 days after major (50-72%) liver resection for colorectal liver metastases for 28 days', 'interventionNames': ['Drug: Placebo capsules']}], 'interventions': [{'name': 'HRX215 capsules', 'type': 'DRUG', 'description': 'HRX215 capsules 250 mg orally twice daily', 'armGroupLabels': ['Active treatment arm major hepatic resection', 'Active treatment minor hepatic resection']}, {'name': 'Placebo capsules', 'type': 'DRUG', 'description': 'placebo capsules matching appearance of HRX215', 'armGroupLabels': ['placebo arm major hepatic resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patrick Starlinger, M.D Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Wolfgang Albrecht, Doctorate of Natural Sciences', 'role': 'CONTACT', 'email': 'info@heparegenix.com', 'phone': '49 7071 7912809'}, {'name': 'Linda Greenbaum, M.D.', 'role': 'CONTACT', 'email': 'l.greenbaum@heparegenix.com', 'phone': '484-343-2409'}], 'overallOfficials': [{'name': 'Linda E Greenbaum, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HepaRegeniX GmbH'}, {'name': 'Patrick Starlinger, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HepaRegeniX GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}