Distal Radius FracturesPhase 1/2X3LTFUNCT06532253
Long-term Safety Trial with NVDX3
A Phase 1/2 study testing NVDX3 in people with Distal Radius Fractures and Degenerative Lumbar Spondylolisthesis, run by Novadip Biosciences at 1 site in Luxembourg.
Trial summary
An study evaluating the long-term safety of all patients previously treated with NVDX3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures, Degenerative Lumbar Spondylolisthesis
- What is being tested?
- NVDX3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteLuxembourg
- Study dates
- 22 Aug 2024to Mar 2036
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria are applicable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luxembourg1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Luxembourg
Luxembourg, 1210
Torsten Gerich, MD, gerich.torsten@chl.lu
About this study
Official title: Long-term Safety Bucket Trial with NVDX3, an Osteogenic Implant of Human Allogenic Origin.
An study evaluating the long-term safety of all patients previously treated with NVDX3.
Read the detailed description
An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the "core NVDX3 trial"). All patients having signed the ICF enter the long term follow-up study.
- Being tested
- NVDX3
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVDX3Drug
NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033)
| Study group | Role | What they receive |
|---|---|---|
| NVDX3 implant | Experimental | NVDX3 implant is a sterilized, dry powder. The total administered quantity of NVDX3 implant depends on the bone defect size/intervertebral disc space. Receives: Drug: NVDX3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of the NVDX3 implant
Description of all SAEs, NVDX3 related AEs and AE of special interest
Measured: Between screening (V0) and 120 months post-core study (V10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start22 Aug 2024
- Primary completionMar 2036 (estimated)
- Study completionMar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novadip Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PrimeVigilance, Data Investigation Company Europe (DICE)
- Responsible party
- Sponsor
- Investigators
- Torsten Gerich, MD, Principal investigator, Centre Hospitalier du Luxembourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532253
- Sponsor's protocol ID
- NVDX3-CLN0X
- Acronym
- X3LTFU
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety Bucket Trial with NVDX3, an Osteogenic Implant of Human Allogenic Origin.
- ClinicalTrials.gov ID
- NCT06532253
- Acronym / sponsor ID
- X3LTFU / NVDX3-CLN0X
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Novadip BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- PrimeVigilance, Data Investigation Company Europe (DICE)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- Mar 2036 (estimated)
- Study completion
- Mar 2036 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An study evaluating the long-term safety of all patients previously treated with NVDX3.
Detailed description
An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the "core NVDX3 trial"). All patients having signed the ICF enter the long term follow-up study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVDX3 implant | Experimental | Drug: NVDX3NVDX3 implant is a sterilized, dry powder. The total administered quantity of NVDX3 implant depends on the bone defect size/intervertebral disc space. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria are applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVDX3NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033) | Drug | NVDX3 implant |
Primary outcome
Long-term safety of the NVDX3 implant
Time frame: Between screening (V0) and 120 months post-core study (V10)
Description of all SAEs, NVDX3 related AEs and AE of special interest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Torsten Gerich, MD principal investigator
Centre Hospitalier du Luxembourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NVDX3 in people with Distal Radius Fractures and Degenerative Lumbar Spondylolisthesis, run by Novadip Biosciences at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denis Dufrane, MD (+3210779220, clinical@novadip.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety of the NVDX3 implant (time frame: Between screening (V0) and 120 months post-core study (V10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.