NCT06097715 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hartl L, Jachs M, Desbalmes C, Schaufler D, Simbrunner B, Paternostro R, Schwabl P, Bauer DJM, Semmler G, Scheiner B, Bucsics T, Eigenbauer E, Marculescu R, Szekeres T, Peck-Radosavljevic M, Kastl S, Trauner M, Mandorfer M, Reiberger T
The differential activation of cardiovascular hormones across distinct stages of portal hypertension predicts clinical outcomes. Hepatol Int. 2021 Oct;15(5):1160-1173. doi: 10.1007/s12072-021-10203-9. Epub 2021 May 21.
Selicean S, Wang C, Guixe-Muntet S, Stefanescu H, Kawada N, Gracia-Sancho J
Regression of portal hypertension: underlying mechanisms and therapeutic strategies. Hepatol Int. 2021 Feb;15(1):36-50. doi: 10.1007/s12072-021-10135-4. Epub 2021 Feb 5.
Sutton H, Dhawan A, Grammatikopoulos T
Non-invasive Markers of Portal Hypertension: Appraisal of Adult Experience and Potential Utilisation in Children. J Pediatr Gastroenterol Nutr. 2018 Apr;66(4):559-569. doi: 10.1097/MPG.0000000000001882.
Zhang M, Jin H, Cao J, Ren R, Jia M, Yang Y, Li X, Chen M, Li S, Huang L, Ling W
Application of Ultrasound Elastography in Assessing Portal Hypertension. Diagnostics (Basel). 2022 Sep 29;12(10):2373. doi: 10.3390/diagnostics12102373.

Clinical, Endoscopic and Radiological Assessment of Portal Hypertension in Children With Chronic Liver Diseases

Clinical trial NCT06097715 - References