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New treatment option for Hypertension, Portal
Official title SHAPE of Portal Hypertension in Children
ClinicalTrials.gov ID: NCT04720456
What this study is testing
What is SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles)?
SHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hypertension, portal.
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
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 21
You may be able to join if
- Patients with a diagnosis of chronic liver disease without portal hypertension.
- Patients with a diagnosis of chronic liver disease with portal hypertension.
You likely can't join if
- people 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.
- people 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...
- History of allergic reaction to Sonazoid
- Patients with biliary atresia with asplenia or polysplenia.
See the full eligibility criteria
- Patients with a diagnosis of chronic liver disease without portal hypertension.
- Patients with a diagnosis of chronic liver disease with portal hypertension.
- people 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.
- people 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
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, 6 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. 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.