Trial · NCT06632457
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH | up to 4.5 years. | MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension |
| Secondary | Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score | At baseline and at Week 76. | |
| Secondary | Key secondary endpoint: Percentage change from baseline in body weight | At baseline and at Week 76. | |
| Secondary | Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline | At baseline and at Week 76. | |
| Secondary | Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE) | At baseline and at Week 76. | |
| Secondary | Percentage change from baseline in liver stiffness in FibroScan® VCTE | At baseline and at Week 76. | |
| Secondary | Time to first occurrence of progression to CSPH | up to 4.5 years. | |
| Secondary | Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to ≥15 | up to 4.5 years. | |
| Secondary | Occurrence of all-cause hospitalisation (first and recurrent) | up to 4.5 years. | |
| Secondary | Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE) | up to 4.5 years. | |
| Secondary | Absolute changes from baseline in lipids (mg/dL) | At baseline and at Week 76. | |
| Secondary | Absolute change from baseline in aspartate aminotransferase (AST) (U/L) | At baseline and at Week 76. | |
| Secondary | Absolute change from baseline in alanine aminotransferase (ALT) (U/L) | At baseline and at Week 76. | |
| Secondary | Absolute change from baseline in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE) | At baseline and at Week 76. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06632457/registered