Phase 3: testing NVD003 for Congenital Pseudarthrosis of Tibia
This study wants to assess the how well it works 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.
Official registry: https://clinicaltrials.gov/study/NCT07112443 · Novadip Biosciences · enrollment listed as 12
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are NVD003, or Iliac Crest Bone Graft. The registry lists allocation as randomized. This study wants to assess the how well it works 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.
They plan to enroll about 12 people at 7 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
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
Interventions: NVD003, Iliac Crest Bone Graft
Primary outcome (registry wording): To assess the efficacy of NVD003 for the surgical treatment of CPT in pediatric participants
Who it is for (from inclusion criteria)
- Ages any to 17 Years
- Participant is of any sex, ≤17 years of age
- Participant has been diagnosed with CPT (with or without NF1)
- Participant has a non-healing Paley type 3 or 4 diaphyseal fracture.4
- Participant is a candidate for surgical treatment using an internal fixation approach (intramedullary rod) based on CPT fracture status and general health status
- Participant has serology and molecular test results at Visits 1 and 2 excluding the presence of human T-cell lymphoma virus, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and syphilis
- Participant can provide an adequate ATC sample volume
- Participant weighs ≥5 kg/11 lb at Screening and on Day 1
Who the registry excludes
- Participant has bilateral CPT
- Participant has evidence of plexiform neurofibroma of any size or nodular fibroma ≥1.2 inches/3 cm on the ipsilateral leg
- Participant has a clinically significant infection at the fracture site or systemic infection
- Participant's CPT fracture involves the metaphysis (i.e., not limited to the diaphysis)
- Participant has a CPT fracture, for which the surgeon intends to use an external fixation system (e.g., Ilizarov, Taylor spatial frame, rail, etc.) instead of, or in addition to, internal fixation
- Participant has an autoimmune disease, with the exception of well-controlled type 1 diabetes or autoimmune thyroid disorders
- Participant has an active (malignant) tumor
Public study contact (from the registry)
Judy Ashworth, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
7 listed- Phoenix Children's Hospital, Inc. — Phoenix, Arizona (recruiting)
- Loma Linda University Health — Loma Linda, California (recruiting)
- LifeBridge Health - International Center for Limb Lengthening — Baltimore, Maryland (recruiting)
- Mayo Clinic — Rochester, Minnesota (recruiting)
+ 3 sites outside the US on the same record
FAQ about this NCT record
Is NCT07112443 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07112443?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07112443?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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