Dasatinib and Quercetin to Treat Fibrotic Non-alcoholic Fatty Liver Disease (NCT05506488) | Clinical Trial Compass
CompletedPhase 1/2
Dasatinib and Quercetin to Treat Fibrotic Non-alcoholic Fatty Liver Disease
Netherlands30 participantsStarted 2023-07-05
Plain-language summary
To examine the effect of dasatinib plus quercetin on liver fibrosis in individuals with biopsy proven NAFLD with fibrosis by performing a double-blind randomized controlled proof-of-principle study
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adult individuals, age \> 18 years
* NAFLD with fibrosis score \>2 according to the Steatosis Activity and Fibrosis score, but no cirrhosis histological diagnosis according to the SAF fibrosis score on a liver biopsy performed \< 6 months before screening in the study and confirmed by central reading during the screening period.
* Individuals agrees to have a liver biopsy performed after the treatment
* Compensated liver disease with the following hematologic and biochemical criteria on entry into protocol:
* ALAT \<10x ULN
* Hemoglobin \> 11g/dL for females and 12 g/dL for males
* White blood cell (WBC) \> 2.5 K/ μL
* Neutrophil count \> 1.5 K μL
* Platelets \> 100 K/μL
* Total bilirubin \<35 μmol/L
* Albumin \>30 g/L
* TP \>80% or INR \<1.4
* Serum creatinine \<1.3 mg/dL (men) or \<1.1 mg/dL (women) or estimated glomerular filtration rate (eGFR) \> 60mL/min/1.73m2
* Have a stable weight since the liver biopsy was performed defined by no more than a 5% loss of initial body weight
* Subjects should be able to give informed consent
Exclusion Criteria:
* Evidence of another form of liver disease
* History of sustained excess alcohol ingestion: daily consumption \>30g/day (3 drinks per day) for males and \>20 g/day (2 drinks per day) for females
* Unstable metabolic condition: weight change \> 5 kg in the last three months, diabetes with poor glycaemic control (HbA1c \> 8.5%), introduction of an antidiabetic or of an anti-obesity drug/m…
What they're measuring
1
The primary endpoint is the binary outcome improvement of fibrosis with at least 1-point without worsening of fibrosis and NAFLD score based on histology after 21 weeks (yes/no). Individuals will be labeled as responder or non-responder.
Timeframe: 21 week
Trial details
NCT IDNCT05506488
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)