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Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Study acronym: PEARL
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 28, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Sep 30, 2022 to Sep 30, 2026 Completion date: Sep 30, 2023 to Dec 31, 2026v5 Show 1 more changeShow less
    • Completion date: Sep 30, 2023 to Dec 31, 2026
  2. Re-verified, no change to tracked fieldsv4
  3. Study sites: 2 to 6 Eligibility criteria shortened, about 10 wordsv3 Show 1 more changeShow less
    • Eligibility criteria shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 1, 2019 to Jan 21, 2020 · Study sites: 0 to 2 · Interventions: Lactulose 667 MG/ML Oral Solution (Drug), Placebo oral tablet (Drug), Rifaximin 550 MG Oral Tablet [XIFAXAN] (Drug) to Lactulose 667 milligram/milliliter Oral Solution (Drug), Placebo oral tablet (Drug), Rifaximin 550 milligram Oral Tablet [XIFAXAN] (Drug) · 3 morev2 Show 6 more changesShow less
    • Start date changed from estimate of Oct 1, 2019 to Jan 21, 2020
    • Study sites: 0 to 2
    • Interventions: Lactulose 667 MG/ML Oral Solution (Drug), Placebo oral tablet (Drug), Rifaximin 550 MG Oral Tablet [XIFAXAN] (Drug) to Lactulose 667 milligram/milliliter Oral Solution (Drug), Placebo oral tablet (Drug), Rifaximin 550 milligram Oral Tablet [XIFAXAN] (Drug)
    • Secondary endpoints revised (9)
    • Study description expanded, about 30 words
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.
Trial Details
NCT Number NCT04073290
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Erasmus Medical Center, Leiden University Medical Center, Maastricht University Medical Center, Radboud University Medical Center, University Medical Center Groningen, Universitaire Ziekenhuizen KU Leuven, Norgine
Conditions Hepatic Encephalopathy, Cirrhosis, Liver, Portal Hypertension, Liver Diseases, Pathological Processes
Enrollment 238 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov