NCT03914716Completed
Imaging of Arthropathy in Boys With Hemophilia in China
Radiogenomics: Personalized Imaging of Arthropathy in Boys With Hemophilia in China
Source: ClinicalTrials.gov · Last updated 19 Apr 2024
Brief summary (registry, in English)
Hemophilia is a genetic condition characterized by marked phenotypic heterogeneity. Bleeding into a joint is the single most important risk factor for the development of hemophilic arthropathy (HA). It is thought that clinical and imaging manifestations of HA are at least partially attributable to genetic polymorphisms unrelated to the hemophilia genotype. Identifying and characterizing biologic factors that could explain differences in susceptibility to joint degeneration of patients with hemophilia would help stratify patients according to the risk of degeneration of their joints and develop personalized therapeutic and prophylactic strategies. This study is conducted in China.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 19 Feb 2019
- Start date
- 21 Mar 2018
- Primary completion date
- 2 Feb 2022
- Lead sponsor
- Andrea Doria
- Diseases
- Haemophilia
- NCT number
- NCT03914716
What you commit to
- Study type: Interventional
- Participants enrolled: 49
- From 21 Mar 2018 to the primary completion date, 2 Feb 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipation of need for major surgery during the study period.
- Social barriers for participation in the study such as long distance between home and the comprehensive care centre, and documented track record of non-compliance to therapies or participation in clinical studies.
Other illness
- History of FVIII inhibitor (titer \>0.6 Bethesda Units \[BU\])
- Association of diseases known to mimic or cause joint diseases such as symptomatic human immunodeficiency virus (HIV) infection, juvenile idiopathic arthritis, and metabolic bone diseases.
- Contraindications to MR imaging (presence of heart pacemakers, metallic foreign bodies in the eye, aneurysm clips, severe claustrophobia).
Lab values
- Chronic renal failure (serum creatinine \>2.0 mg /dL).
- Chronic liver disease (alanine aminotransferase \[ALT\] \>200 U/L).
Other
- Clinically documented immunodeficiency.
- Neuro-developmental/behavioral problems.
Who the study is looking for
- Hemophilia A with baseline FVIII levels of \<2%
- Clinical history of ≥ 50 exposure days to FVIII prior to the study start.
- On-demand treatment, prophylaxis FVIII infusions or treatment with plasma-derived products for \>3 months prior to enrollment into the study.
Age in the registry: 4 years to 11 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.