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NCT04720456 · ClinicalTrials.gov registry record · Phase 2
SHAPE of Portal Hypertension in Children
A Phase 2 study of Hypertension, Portal, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04720456: Recruiting Phase 2 study of Hypertension, Portal, sponsored by Thomas Jefferson University.
NCT04720456 is a Phase 2 study of Hypertension, Portal that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 120 participants, above the 49-participant average among 3 other Hypertension, Portal trials with a reported enrollment target (145% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04720456, a Phase 2 study of Hypertension, Portal, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles)
- DRUG SHAPE measurement using the ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres)
Study Locations (1)
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2025-08 |
| Phase | Phase 2 |
What NCT04720456 shows while recruiting
NCT04720456 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 49-participant average among 3 other Hypertension, Portal trials with a reported enrollment target (145% higher).
The record links to 1 condition, with Hypertension, Portal appearing as the primary indexed condition, and to 2 interventions - of which SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles) is the first listed.
NCT04720456 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04720456 about?
NCT04720456 is a clinical study titled "SHAPE of Portal Hypertension in Children". 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, var...
What is the current status of trial NCT04720456?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2021-11-03. Estimated completion is 2025-08.
What conditions does trial NCT04720456 study?
This clinical trial studies the following conditions: Hypertension, Portal.
What interventions are being tested in trial NCT04720456?
The interventions under investigation include: SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles) (DRUG), SHAPE measurement using the ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres) (DRUG).
Who is sponsoring clinical trial NCT04720456?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04720456 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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