NCT05566548 - 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)

Bajaj JS, O'Leary JG, Tandon P, Wong F, Garcia-Tsao G, Kamath PS, Maliakkal B, Biggins SW, Thuluvath PJ, Fallon MB, Subramanian RM, Vargas HE, Lai J, Thacker LR, Reddy KR
Hepatic Encephalopathy Is Associated With Mortality in Patients With Cirrhosis Inde
Karimzadeh P, Fallahi M, Kazemian M, Taslimi Taleghani N, Nouripour S, Radfar M
Bilirubin Induced Encephalopathy. Iran J Child Neurol. 2020 Winter;14(1):7-19. Review.
Lee HA, Jung JY, Lee YS, Jung YK, Kim JH, An H, Yim HJ, Jeen YT, Yeon JE, Byun KS, Um SH, Seo YS
Direct Bilirubin Is More Valuable than Total Bilirubin for Predicting Prognosis in Patients with Liver Cirrhosis. Gut Liver. 2021 Jul 15;15(4):599-605. doi:
López-Velázquez JA, Chávez-Tapia NC, Ponciano-Rodríguez G, Sánchez-Valle V, Caldwell SH, Uribe M, Méndez-Sánchez N
Bilirubin alone as a biomarker for short-term mortality in acute-on-chronic liver failure: an important prognostic indicator. Ann Hepatol.
Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J, Durand F, Gustot T, Saliba F, Domenicali M, Gerbes A, Wendon J, Alessandria C, Laleman W, Zeuzem S, Trebicka J, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium
Acute
Tang L, Zhang M, Li X, Zhang L
Glucuronidated bilirubin: Significantly increased in hepatic encephalopathy. Prog Mol Biol Transl Sci. 2019;162:363-376. doi: 10.1016/bs.pmbts.2018.12.009. Epub 2019 Mar 6.
Tapper EB, Rahimi RS
Low-Value Levels: Ammonia Testing Does Not Improve the Outcomes of Overt Hepatic Encephalopathy. Am J Gastroenterol. 2020 May;115(5):685-686. doi: 10.14309/ajg.0000000000000454.

The Importance of Bilirubin Molecular Species in Patients With Liver Cirrhosis Who Develop Hepatic Encephalopathy and Patients With Acute-on-chronic Liver Failure

Details for clinical trial NCT05566548

Clinical trial NCT05566548 - References