NCT04720456 SHAPE of Portal Hypertension in Children
| NCT ID | NCT04720456 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Thomas Jefferson University |
| Condition | Hypertension, Portal |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-11-03 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2021-11-03 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-threatening complications, the most frequent of which is bleeding from esophageal varices. In children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. Despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. Hence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.
Eligibility Criteria
Inclusion Criteria: * Patients with a diagnosis of chronic liver disease without portal hypertension. * Patients with a diagnosis of chronic liver disease with portal hypertension. Exclusion Criteria: * 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
Contact & Investigator
Flemming Forsberg, PhD
PRINCIPAL INVESTIGATOR
Thomas Jefferson University
Frequently Asked Questions
Who can join the NCT04720456 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 21 Years, studying Hypertension, Portal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04720456 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04720456 currently recruiting?
Yes, NCT04720456 is actively recruiting participants. Contact the research team at gabbertm@email.chop.edu for enrollment information.
Where is the NCT04720456 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT04720456 clinical trial?
NCT04720456 is sponsored by Thomas Jefferson University. The principal investigator is Flemming Forsberg, PhD at Thomas Jefferson University. The trial plans to enroll 120 participants.