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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: Recruiting Phase 3 study of Congenital Pseudarthrosis of Tibia, sponsored by Novadip Biosciences.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall healing at 12 months, defined as a binary (yes/no) outcome derived from the following 3 outcomes: * Radiographic healing, defined as a score ≥13 on the modified Radiological Union Scale for Tibia (mRUST) scale (range 1 to 16) assessed by independent central readers (ICRs) * Clinical healing measured by the absence of pain with weight-bearing, based on clinician's assessment * No use of secondary interventions to promote or accelerate bone healing All 3 criteria must be met for a "yes" o
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 |
What NCT07112443 shows while recruiting
NCT07112443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07112443's enrollment target sits among peer trials
12 1985th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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