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Study in Patients With Decompensated Liver Cirrhosis

Study acronym: OPAL
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Apr 3, 2027 to Apr 3, 2030
    • Study description expanded, about 19 words
    • Site details revised at 2 of 12 sites
    v7
  2. Study sites: 17 to 12
    • Primary and study completion dates: Feb 1, 2027 to Apr 3, 2027
    v6
  3. Site details revised at 8 of 17 sitesv5
  4. Enrollment target: 240 to 24
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 18 to 17
    v4
  5. Primary completion date: Dec 31, 2024 to Feb 1, 2027
    • Study sites: 9 to 18
    • Study completion date: Nov 3, 2026 to Feb 1, 2027
    v3
  6. Eligibility criteria expanded, about 35 wordsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient.
Trial Details
NCT Number NCT06380335
Lead Sponsor Resolution Therapeutics Limited
Conditions
(from sponsor)		 Liver Cirrhosis
Related terms End Stage Liver Disease, Hepatic Encephalopathy, Liver Cirrhosis
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov