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New treatment option for Congenital Pseudarthrosis of Tibia
Official title A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
ClinicalTrials.gov ID: NCT07112443
What this study is testing
What is NVD003?
NVD003 is an investigational medicine, being studied as a potential treatment for congenital pseudarthrosis of tibia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- Participant's parent(s)/legal guardian(s) have provided written informed consent (and assent has been provided by the participant, depending on age)...
- 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...
You likely can't join if
- 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.)...
- Participant has an autoimmune disease, with the exception of well-controlled type 1 diabetes or autoimmune thyroid disorders.
See the full eligibility criteria
- Participant's parent(s)/legal guardian(s) have provided written informed consent (and assent has been provided by the participant, depending on age) for the study.
- 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.
- Participant is not pregnant or lactating.
- If participant is of childbearing potential, is practicing highly effective methods of birth control from Screening to the end of the study:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral
- Intravaginal
- Transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable
- Implantable
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence, defined as refraining from heterosexual intercourse during study participation, is acceptable if this is the participant's usual lifestyle; periodic abstinence (calendar, symptothermal, post-ovulation...
- Participant and parent(s)/legal guardian(s) are able to understand all study information provided and are willing to return to the study facility for all visits, including follow-up evaluations.
- 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.
- Participant has documented metabolic bone disease or any disorder, such as, but not limited, to osteogenesis imperfecta and osteomalacia, that could interfere with bone healing and bone metabolism.
- Participant has any chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, vitamin K antagonists, immunosuppressant therapy, or...
- Participant has any history of allergic reaction or any anticipated hypersensitivity to any anesthetic agent or any potential hypersensitivity to any of the components of the NVD003 graft (including the CMRL1066...
- Participant has received any investigational product (including a device) within 60 days before enrollment in the study.
- Participant would be concurrently enrolled in another clinical study while participating in this study.
- Participant has any clinically significant hematologic, renal, hepatic, and coagulation laboratory abnormalities (i.e., complete blood count, prothrombin time/international normalized ratio, Chem-7, liver function...
- Participant or participant's parent(s)/legal guardian(s) have an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Loma Linda, California, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Brussels, Brussels Capital, Belgium
- Amiens, Picardie, France
- Esplugues de Llobregat, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Loma Linda, California, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; Brussels, Brussels Capital, Belgium; Amiens, Picardie, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.