Hepatic Encephalopathy Clinical Trial
Official title:
Assessing Patient Engagement and Understanding in Hepatic Encephalopathy Clinical Research
| NCT number | NCT06201988 |
| Other study ID # | 67278255 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2025 |
| Est. completion date | January 2027 |
This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in hepatic encephalopathy clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors. In essence, this trial aims to deepen understanding of the factors influencing participation in hepatic encephalopathy clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | January 2027 |
| Est. primary completion date | January 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Signed Written Informed Consent - Aged = 18 years old - No prior treatment for hepatic encephalopathy Exclusion Criteria: - Participant is actively receiving study therapy in another - Inability to provide written informed consent - Women of childbearing potential without a negative pregnancy test; or women who are lactating. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Power Life Sciences | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
United States,
Bureau C, Thabut D, Jezequel C, Archambeaud I, D'Alteroche L, Dharancy S, Borentain P, Oberti F, Plessier A, De Ledinghen V, Ganne-Carrie N, Carbonell N, Rousseau V, Sommet A, Peron JM, Vinel JP. The Use of Rifaximin in the Prevention of Overt Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt : A Randomized Controlled Trial. Ann Intern Med. 2021 May;174(5):633-640. doi: 10.7326/M20-0202. Epub 2021 Feb 2. — View Citation
Gairing SJ, Mangini C, Zarantonello L, Gioia S, Nielsen EJ, Danneberg S, Gabriel M, Ehrenbauer AF, Bloom PP, Ripoll C, Sultanik P, Galle PR, Labenz J, Thabut D, Zipprich A, Lok AS, Weissenborn K, Marquardt JU, Lauridsen MM, Nardelli S, Montagnese S, Labenz C. Prevalence of Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis: A Multicenter Study. Am J Gastroenterol. 2023 Dec 1;118(12):2191-2200. doi: 10.14309/ajg.0000000000002251. Epub 2023 Mar 20. — View Citation
Nardelli S, Gioia S, Faccioli J, Riggio O, Ridola L. Hepatic encephalopathy - recent advances in treatment and diagnosis. Expert Rev Gastroenterol Hepatol. 2023 Mar;17(3):225-235. doi: 10.1080/17474124.2023.2183386. Epub 2023 Feb 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of patients who decide to join in a hepatic encephalopathy clinical trial | 3 months | ||
| Primary | Number of hepatic encephalopathy patients who remain in clinical trial until completion | 12 months |
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