Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Distal Radius fracture
• To document the long-term safety of the NVDX3 implant.
Key facts
- Sponsor
- Novadip Biosciences
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 22 Aug 2024 → ongoing
- Decision date (initial)
- 2024-07-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
• To document the long-term safety of the NVDX3 implant.
Conditions and MedDRA coding
Distal Radius fracture
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Long-term safety bucket trial with NVDX3, an osteogenic implant of human allogenic origin. Long Term Follow Up Safety Trial
|
Not Applicable | None |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Not applicable
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-508321-27-00 | 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. | Novadip Biosciences |
| 2024-511661-11-00 | Long-term safety bucket trial with NVDX3, an osteogenic implant of human allogenic origin | Novadip Biosciences |
| 2023-508471-37-00 | A proof-of-concept study with NVDX3, an osteogenic implant of human allogenic origin, in the treatment of low grade degenerative lumbar spondylolisthesis by interbody spine fusion in adults. | Novadip Biosciences |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patient being implanted with NVDX3.
- Previously participated to one of the NVDX3 core clinical trials.
- Patient accepts to comply to a yearly follow-up safety visit for 10 additional years
- Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.
Exclusion criteria 1
- No exclusion criteria are applicable
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Description of all SAEs, NVDX3 related AEs and AE of special interest from screening till 120 months post- core study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novadip Biosciences
- Sponsor organisation
- Novadip Biosciences
- Address
- Rue Granbonpre 11
- City
- Mont-Saint-Guibert
- Postcode
- 1435
- Country
- Belgium
Scientific contact point
- Organisation
- Novadip Biosciences
- Contact name
- Denis Dufrane
Public contact point
- Organisation
- Novadip Biosciences
- Contact name
- Denis Dufrane
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Luxembourg | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier De Luxembourg
Orthopedics and traumatology, 4 Rue Nicolas-Ernest Barble, 1210, Luxembourg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Luxembourg | 2024-08-22 | 2024-08-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-000186-14_redacted | 5.0 |
| Protocol (for publication) | Safety Management Plan_redacted | 1.1 |
| Recruitment arrangements (for publication) | L2_Letter of no recruitment material 2024-511661-11-00_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_CLEAN | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_track changes | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_GE_CLEAN | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_GE_track changes | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_secondary use_DE_clean | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_secondary use_DE_track changes | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_secondary use_FR_clean | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_secondary use_FR_track changes | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-000186-14_redacted | 5.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-06 | Luxembourg | Acceptable 2024-07-02
|
2024-07-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-10 | Luxembourg | Acceptable 2025-02-10
|
2025-02-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-02 | Luxembourg | Acceptable 2025-02-10
|
2025-09-02 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-18 | Luxembourg | Acceptable 2026-03-30
|
2026-03-31 |