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Trial · NCT06687265

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primaryeffect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.after 28 days of treatmentHVPG measures before and after metformin or placebo treatment
Secondarythe rate of patients with a clinically significant improvement in HVPGafter 28 days of treatmentChange in arterial pressure after treatment : HVPG \> or = 12 mm Hg, or at least a 10% reduction from baseline,
SecondaryChange in cirrhosis severity MELD scoreafter 28 days of treatmentMELD (Model for End-Stage Liver Disease) score classification (6-40 with high score is worse outcome)
SecondaryChange in cirrhosis severity Child-Pugh scoreafter 28 days of treatmentChild-Pugh classification or Child-Turcotte-Pugh classification (5-15 with high score is worse outcome)
Secondarychange in systemic haemodynamicsafter 28 days of treatmentThe size (diameter) of a blood vessel.
Secondarythe tolerability of metformin in patients with cirrhosis and a HVPG ≥ 12 mm Hgafter 28 days of treatmenttreatment compliance
SecondaryMaximum metformin plasma levelafter 28 days of treatmentplasma level (at 2h30 of last dose)
SecondaryRelative changes in HVPGday 28HVPG measure
SecondaryChange in arterial pressureafter 28 days of treatmentHVGP
Secondarythe safety of metformin in patients with cirrhosis and a HVPG ≥ 12 mm Hg30 days after the beginning of treatmentcomplication and adverse event evaluate by CTCAE guideline during treatment
SecondaryChange in liver steatosisafter 28 days of treatmentControlled Attenuation Parameter with FibroScan®
SecondaryChange in markers of systemic inflammationafter 28 days of treatment.
SecondaryChange in markers of hepatocyte stressafter 28 days of treatmenthepatocyte large extracellular vesicles
SecondaryChange in markers of endothelial functionafter 28 days of treatment
SecondaryChange in platelet countafter 28 days of treatment
SecondaryChange in liver stiffness by VCTEafter 28 days of treatmentusing FibroScan®
SecondaryChange in liver stiffness by 2D-shear wave elastographyafter 28 days of treatmentusing Aixplorer®
SecondaryChange in SPLEEN stiffness by VCTEafter 28 days of treatmentusing FibroScan®
SecondaryChange in spleen stiffness by 2D-shear wave elastographyafter 28 days of treatmentusing Aixplorer®

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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