Status:
RECRUITING
SHAPE of Portal Hypertension in Children
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Children's Hospital of Philadelphia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hypertension, Portal
Eligibility:
All Genders
6-21 years
Phase:
PHASE2
Brief Summary
Early diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. Both cirrhotic and non-cirrhotic portal hypertension can result in life-threate...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of chronic liver disease without portal hypertension.
- Patients with a diagnosis of chronic liver disease with portal hypertension.
Exclusion
- Subjects who are pregnant.
- Patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products.
- Subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded.
- History of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
- History of allergic reaction to Sonazoid
- Patients with biliary atresia with asplenia or polysplenia.
- Patients with prior liver transplant.
- Patients with cystic fibrosis.
- Patients with chronic lung disease.
- Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.
- Adults not competent/impaired.
- Patients with significant heart disease or severe congenital heart disease
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04720456
Start Date
November 3 2021
End Date
August 1 2025
Last Update
February 11 2025
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104