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A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial).

Study acronym: COMBAT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Sep 2025 → Oct 31, 2026
See other at-risk trials from European Foundation for Study of Chronic Liver Failure

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2025 to Oct 31, 2026
    • Trial status changed: Unknown → Recruiting
    • Site details revised at 8 of 9 sites
    v5
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Primary endpoints: 2 to 1v4 Show 5 more changesShow less
    • Trial status: Recruiting to Unknown
    • Study sites: 8 to 9
    • Primary and study completion dates: Mar 2025 to Sep 2025
    • Eligibility criteria expanded, about 55 words
    • Collaborators expanded, about 5 words
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2024 to Jul 1, 2024
    • Study sites: 0 to 8
    v3
  5. Start date: Sep 2023 to Mar 2024v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to determine primarily whether a combinatorial therapy based on the administration of human albumin and enoxaparin is safe and effective in patients with decompensated cirrhosis discharged from the hospital. The main questions it aims to answer are: * Is this combinatorial therapy safe and tolerable? * Is this combinatorial therapy effective? * does this combinatorial therapy cost more or less than standard medical therapy? Participants will attend to study visits in which several test will be performed to asses disease evolution while they are taking study medication. Researchers will compare experimental group treated with combinatorial therapy plus standard treatment with control group treated with standard treatment to see if there are differences in the responses to the questions raised above.
Trial Details
NCT Number NCT05895136
Lead Sponsor European Foundation for Study of Chronic Liver Failure
Collaborators: Horizon 2020 - European Commission
Conditions
(from sponsor)		 Liver Cirrhosis, Decompensated Cirrhosis of Liver, Acute on Chronic Liver Failure (ACLF)
Related terms Acute-On-Chronic Liver Failure, Liver Cirrhosis, Liver Diseases
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov