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NCT07112443 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
A Phase 3 study of Congenital Pseudarthrosis of Tibia, sponsored by Novadip Biosciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
- 6
- Study locations
NCT07112443 is a Phase 3 study of Congenital Pseudarthrosis of Tibia that is actively recruiting participants, run by Novadip Biosciences. The registered enrollment target is 12 participants. The trial reports 6 study locations across 6 states.
The verdict
NCT07112443, a Phase 3 study of Congenital Pseudarthrosis of Tibia, is actively recruiting participants, sponsored by Novadip Biosciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.
Conditions Studied
Interventions
- BIOLOGICAL NVD003
- PROCEDURE Iliac Crest Bone Graft
Study Locations (6)
Arizona
- Phoenix Children's Hospital, Inc. - Phoenix
California
- Loma Linda University Health - Loma Linda
Maryland
- LifeBridge Health - International Center for Limb Lengthening - Baltimore
Minnesota
- Mayo Clinic - Rochester
Brussels Capital
- Cliniques Universitaires Saint-Luc ASBL (CUSCL) - Brussels
Picardie
- CHU Amiens-Picardie - Amiens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-09-02 |
| Est. Completion | 2027-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07112443
The ClinicalTrials.gov registry entry for NCT07112443 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novadip Biosciences, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Congenital Pseudarthrosis of Tibia appearing as the primary indexed condition, and to 2 interventions - of which NVD003 is the first listed.
NCT07112443 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Arizona, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT07112443 about?
NCT07112443 is a clinical study titled "A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.". The purpose of this study is to assess the efficacy and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.
What is the current status of trial NCT07112443?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2025-09-02. Estimated completion is 2027-07.
What conditions does trial NCT07112443 study?
This clinical trial studies the following conditions: Congenital Pseudarthrosis of Tibia.
What interventions are being tested in trial NCT07112443?
The interventions under investigation include: NVD003 (BIOLOGICAL), Iliac Crest Bone Graft (PROCEDURE).
Who is sponsoring clinical trial NCT07112443?
This trial is sponsored by Novadip Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07112443 being conducted?
This trial has 6 study locations across Arizona, California, Maryland, Minnesota, Brussels Capital. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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