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Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Publications: details revised at 4 of 6 entriesv8
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2025 to Jun 24, 2025
    • Site details revised
    v7
  3. Start date: Oct 1, 2024 to May 1, 2025
    • Interventions: Arginine (Drug), Branched-Chain Amino Acids (Drug), Human albumin infusion at a modified dosage (Drug), Human albumin infusion at a routine… to Arginine (Drug), Branched-Chain Amino Acids (Drug), Human albumin infusion at a modified dosage (Drug), Human albumin infusion at a routine…
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Start date: Jul 1, 2024 to Oct 1, 2024v4 Show 4 more changesShow less
    • Interventions: Arginine (Drug), Branched-Chain Amino Acids (Drug), Human albumin infusion at a modified dosage (Drug), Human albumin infusion at a routine… to Arginine (Drug), Branched-Chain Amino Acids (Drug), Human albumin infusion at a modified dosage (Drug), Human albumin infusion at a routine…
    • Eligibility criteria revised
    • Publications: details revised at 4 of 6 entries
    • Study description expanded, about 1 word
Show 2 earlier versionsHide 2 earlier versions
  1. Interventions: Human albumin infusion at a modified dosage (Drug), Human albumin infusion at a routine dosage (Drug), Lactulose, rifaximin, ornithine… to Arginine (Drug), Branched-Chain Amino Acids (Drug), Human albumin infusion at a modified dosage (Drug), Human albumin infusion at a routine…v3
  2. Primary endpoint revisedv2 Show 4 more changesShow less
    • Interventions: Human albumin infusion at a modified dosage (Drug), Human albumin infusion at a routine dosage (Drug), Standard treatment (Drug) to Human albumin infusion at a modified dosage (Drug), Human albumin infusion at a routine dosage (Drug), Lactulose, rifaximin, ornithine…
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Publications: 5 to 6
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.
Trial Details
NCT Number NCT06483737
Lead Sponsor General Hospital of Shenyang Military Region
Conditions
(from sponsor)		 Overt Hepatic Encephalopathy
Related terms Hepatic Encephalopathy, Inflammation, Liver Cirrhosis
Enrollment 174 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov