Clinical Trial

A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.

Recruiting Phase 3
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-01; most recent amendment 2026-03-31.
Status change: Not Yet Recruiting → Recruiting 2025-09-04
Trial Details
NCT Number NCT07112443
Lead Sponsor Novadip Biosciences
Conditions Congenital Pseudarthrosis of Tibia
Enrollment 12 participants
Start Date 2025-09-02
Primary Completion 2026-10 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-01