Clinical trial NCT06201988: Revealing Engagement Patterns Among Hepatic Encephalopathy Patients
Official title: Assessing Patient Engagement and Understanding in Hepatic Encephalopathy Clinical Research
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatic Encephalopathy
Keywords: Hepatic Encephalopathy
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hepatic encephalopathy who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of patients who decide to join in a hepatic encephalopathy clinical trial
timeFrame: 3 months
measure: Number of hepatic encephalopathy patients who remain in clinical trial until completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.