RecruitingInterventionalPhase 3Last updated Apr 1, 2026

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

A Phase 3 Randomized, Controlled Study to Assess the Efficacy and Safety of NVD003 Compared With Iliac Crest Bone Graft in Pediatric Participants Treated Surgically for Congenital Pseudarthrosis of the Tibia

Overview

ClinicalTrials.gov ID: NCT07112443
Lead Sponsor: Novadip BiosciencesINDUSTRY
Brief 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.
Study Type: Interventional

Status

Overall Status: Recruiting
Start Date: Sep 2, 2025Actual
Primary Completion Date: Oct 2026Estimated
Completion Date: Jul 2027Estimated

Study Record Dates

First Submitted: Jul 23, 2025
First Submitted that Met QC Criteria: Aug 1, 2025
First Posted: Aug 8, 2025Actual
Last Update Submitted that Met QC Criteria: Mar 31, 2026
Last Update Posted: Apr 1, 2026Actual
Last Verified: Mar 2026

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