Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT05987033
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2023-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proof-of-concept Study with NVDX3 for Treatment of Distal Radius Fractures.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint: evaluation of SAEs and NVDX3 related AEs', 'timeFrame': 'Between screening (V1) and 12-months post- IS (V8)', 'description': 'Evaluation of all SAEs and NVDX3 related AEs'}], 'secondaryOutcomes': [{'measure': 'Safety: all acute SAEs and NVDX3 related AEs', 'timeFrame': 'Between screening (V1) and 6 weeks post-IS (V5)', 'description': 'Description of all acute SAEs and NVDX3 related AEs'}, {'measure': 'Safety: all SAEs and NVDX3 related AEs', 'timeFrame': 'Beyond 6 weeks (V5 excluded) until 12 months post-IS', 'description': 'Description of all SAEs and NVDX3 related AEs'}, {'measure': 'Safety: TEAEs', 'timeFrame': 'a. Between screening and week 6 (V5 included) b. Between week 6 (V5 excluded) till month 12 (V8 included) c. through study completion', 'description': 'Description of Treatment Emergent AEs (TEAEs)'}, {'measure': 'Safety: related and unexpected (S)AEs', 'timeFrame': 'Between inclusion and 13 months post-IS', 'description': 'Description of related and unexpected (S)AEs'}, {'measure': 'Safety: AESI', 'timeFrame': 'Between inclusion and 13 months post-IS', 'description': 'Description of AE of Special Interest (AESI)'}, {'measure': 'Safety: lab data', 'timeFrame': 'Between inclusion and 13 months post-IS', 'description': 'Description of lab data'}, {'measure': 'Safety: vital signs', 'timeFrame': 'Between inclusion and 13 months post-IS', 'description': 'Description of vital signs: body temperature, pulse rate, respiratory rate and blood pressure'}, {'measure': 'Efficacy: Radiological assessments on Computed Tomography (CT) data using the extended Lane and Sandhu Scoring tool (eLSS)', 'timeFrame': 'At 3 and 12-months post-IS', 'description': 'Radiological assessments on Computed Tomography data (CT) using the extended Lane and Sandhu Scoring tool (eLSS) compared to HD: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score'}, {'measure': 'Efficacy: Radiological assessments on X-ray using the eLSS tool', 'timeFrame': 'At HD, 2-, 6-weeks, 3-,6- and 12-months post-IS', 'description': 'Radiological assessments on X-ray using the eLSS tool compared to the peri-operative x-ray acquisitions: evaluation of bone formation, union and remodeling status and evaluation of total extended Lane and Sandhu Score'}, {'measure': 'Efficacy: Clinical assessments', 'timeFrame': 'At 2-,6 weeks, 3-, 6-, and 12-months post- IS', 'description': 'Following clinical assessment will be performed compared to HD: Grip strength measure with a hydraulic hand dynamometer'}, {'measure': 'Efficacy: Clinical assessments', 'timeFrame': 'At 2-,6 weeks, 3-, 6-, and 12-months post- IS', 'description': "Following clinical assessment will be performed compared to HD: Modified Mayo Wrist Score (MMWS): A physician-based scoring evaluating the patients' pain, active flexion/extension arc, grip strength and ability to return to regular employment or activities."}, {'measure': 'Efficacy: Clinical assessments', 'timeFrame': 'At 2-,6 weeks, 3-, 6-, and 12-months post- IS', 'description': "Following clinical assessment will be performed compared to HD: PRWE Questionnaire: A patient reported scoring evaluating the patients' wrist pain and disability"}, {'measure': 'Efficacy: NRS-pain', 'timeFrame': 'At HD, 2-,6 weeks, 3-, 6-, and 12-months post-IS', 'description': "NRS-pain, a patient reported scoring evaluating the patients' pain compared to Screening"}, {'measure': 'Exploratory: Radiological assessments on Dual Energy CT data (DECT)', 'timeFrame': 'At 3-, and 12-months post-IS', 'description': 'Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to NVDX3 density.'}, {'measure': 'Exploratory: Radiological assessments on Dual Energy CT data (DECT)', 'timeFrame': 'At 3-, and 12-months post-IS', 'description': 'Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of NVDX3.'}, {'measure': 'Exploratory: Radiological assessments on Dual Energy CT data (DECT)', 'timeFrame': 'At 3-, and 12-months post-IS', 'description': 'Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to the composition of surrounding tissue.'}, {'measure': 'Exploratory: Radiological assessments on Dual Energy CT data (DECT)', 'timeFrame': 'At 3-, and 12-months post-IS', 'description': 'Explore non-conventional evaluation methods using CT and Dual Energy Computed Tomography (DECT) imaging, compared to HD, including but not limited to bone mineral density of native bone.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Radius Fractures']}, 'descriptionModule': {'briefSummary': 'Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.', 'detailedDescription': 'This is a prospective, single arm, monocentric first-in-human PoC study in adult patients, suffering from a distal radius fracture, treated during the surgical intervention with NVDX3, an osteogenic implant from human allogeneic origin.\n\nAs per standard of care, patients with DRF are followed up to 3 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 12 months post-implant surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients within the age range of ≥18 years to ≤80 years.\n2. Patient diagnosed with DRF with confirmed:\n\n 1. Classification AO/ATO: C2 and C3 - Intra-articular \\& multifragmentation.\n 2. Estimated volume of the targeted bone void should not exceed 5cc.\n 3. Availability of diagnostic AP and LAT X-ray or CT scan.\n3. Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis.\n4. Patient fulfills criteria for undergoing a surgical intervention.\n5. Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.\n\nExclusion Criteria:\n\n1. Open DRF or closed DRF with increased infection risk.\n2. Injury to the median nerve.\n3. Previous fracture of the target distal radius.\n4. Documented disease limiting mobility and functional assessments (eg. Grip strength test).\n5. Dependency on crutches or any comparable walking aids.\n6. Patient is overweight, has a BMI ≥35.\n7. Presence of clinically significant infection at the target implant site or systemic infection.\n8. History of allergic reaction or any anticipated hypersensitivity to any of the anticipated:\n\n 1. Osteosynthesis materials (PEEK plate and screws).\n 2. Anesthetic agents.\n 3. Components of the NVDX3 implant.\n9. Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders.\n10. Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg.\n11. Presence of an active tumor.\n12. Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism.\n13. Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy.\n14. Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening.\n15. Any history of experimental therapy with another investigational drug within 60 days prior to screening.\n16. Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an effective method of birth control3 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study.\n17. Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results."}, 'identificationModule': {'nctId': 'NCT05987033', 'briefTitle': 'Proof-of-concept Study with NVDX3 for Treatment of Distal Radius Fractures.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novadip Biosciences'}, 'officialTitle': 'A First-in-human Proof-of-concept Study with NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Distal Radius Fractures in Adults.', 'orgStudyIdInfo': {'id': 'NVDX3-CLN01'}, 'secondaryIdInfos': [{'id': '2022-002304-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVDX3 implant', 'interventionNames': ['Drug: NVDX3']}], 'interventions': [{'name': 'NVDX3', 'type': 'DRUG', 'description': 'NVDX3 is implanted during a single surgical intervention.', 'armGroupLabels': ['NVDX3 implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1210', 'city': 'Luxembourg', 'country': 'Luxembourg', 'facility': 'Centre Hospitalier de Luxembourg', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}], 'overallOfficials': [{'name': 'Torsten Gerich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier du Luxembourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novadip Biosciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PrimeVigilance', 'class': 'INDUSTRY'}, {'name': 'Data Investigation Company Europe (DICE)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}