Revealing Engagement Patterns Among Hepatic Encephalopathy Patients

NCT06201988 | Not Yet Recruiting

• 1 other identifier: 67278255
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Keywords

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to join in a hepatic encephalopathy clinical trial

  3 months

• Number of hepatic encephalopathy patients who remain in clinical trial until completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Signed Written Informed Consent
• Aged ≥ 18 years old
• No prior treatment for hepatic encephalopathy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• 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.

  PMID: 36843291 BACKGROUND

• 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.

  PMID: 36940426 BACKGROUND

• 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.

  PMID: 33524293 BACKGROUND

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 11, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

US (1)