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Dasatinib and quercetin, a combination of senolytics to treat fibrotic non-alcoholic fatty liver disease; The TRUTH study
EU CTIS ID: 2024-517593-21-00
What this study is testing
To examine the effect of oral dasatinib plus quercetin on liver fibrosis as assessed by histology in individuals with biopsy-proven NAFLD with fibrosis by performing a double‐blind randomized controlled proof‐of‐principle study. 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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult individuals, age > 18 ≤70 years
- NAFLD according to Non-invasive liver tests (FIB-4, APRI)
- Individuals agree to have a liver biopsy performed after the treatment
- Compensated liver disease with the following hematologic and biochemical criteria on entry into study: o ALAT <10x ULN o Hemoglobin > 11g/dL for females and 12 g/dL for males o White blood cell (WBC) > 2.5 K/ μL o Neutrophil count > 1.5 K μL o Platelets > 100 K/μL o Total bilirubin <35 μmol/L o Albumin >30 g/L o TP >80% or INR <1.4 o Serum creatinine <1.3 mg/dL (men) or <1.1 mg/dL (women) or estimated glomerular filtration rate (eGFR) > 60mL/min/1.73m
- Have a stable weight defined by no more than a 5% loss of initial body weight
- Negative pregnancy test or post-menopausal. Women with childbearing potential (i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile) must be using a highly effective method of contraception (i.e. combined (estrogen and progestogen containing) hormonal/ progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormonereleasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
You likely can't join if
- Evidence of another form of liver disease
- Contra-indication for liver biopsy
- History of/or current cardiac dysrhythmias and/or a history of cardiovascular events including myocardial infarction, except patients with only well-controlled hypertension
- QTc >450 msec on ECG
- individuals who are lactose hypersensitive or have lactase deficiency
- Pregnancy/lactation or inability to adhere to adequate contraception in women of child- bearing potentia
See the full eligibility criteria
- Adult individuals, age > 18 ≤70 years
- NAFLD according to Non-invasive liver tests (FIB-4, APRI)
- Individuals agree to have a liver biopsy performed after the treatment
- Compensated liver disease with the following hematologic and biochemical criteria on entry into study: o ALAT <10x ULN o Hemoglobin > 11g/dL for females and 12 g/dL for males o White blood cell (WBC) > 2.5 K/ μL o Neutrophil count > 1.5 K μL o Platelets > 100 K/μL o Total bilirubin <35 μmol/L o Albumin >30 g/L o TP >80% or INR <1.4 o Serum creatinine <1.3 mg/dL (men) or <1.1 mg/dL (women) or estimated glomerular filtration rate (eGFR) > 60mL/min/1.73m
- Have a stable weight defined by no more than a 5% loss of initial body weight
- Negative pregnancy test or post-menopausal. Women with childbearing potential (i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile) must be using a highly effective method of contraception (i.e. combined (estrogen and progestogen containing) hormonal/ progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormonereleasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
- Subjects should be able to give informed consent
- Evidence of another form of liver disease
- Contra-indication for liver biopsy
- History of/or current cardiac dysrhythmias and/or a history of cardiovascular events including myocardial infarction, except patients with only well-controlled hypertension
- QTc >450 msec on ECG
- individuals who are lactose hypersensitive or have lactase deficiency
- Pregnancy/lactation or inability to adhere to adequate contraception in women of child- bearing potentia
- Use of prescribed drugs dependent on CYP3A4 with narrow therapeutic window and strong inducers or inhibitors of CYP3A4
- Use of H2-antagonists and/or Proton Pump Inhibitors
- 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 unstable glycaemic control introduction of an antidiabetic or anti-obesity drug; malabsorptive or restrictive bariatric (weight loss) surgery in the past 6 months prior to screening
- Bariatric surgery
- ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose oestrogens, methotrexate, tetracycline or amiodarone in the previous 6 months
- Significant systemic or major illnesses other than liver disease, including congestive heart failure (class C and D of the AHA), unstable coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease, active malignancy, compromised immunity
- Body mass index (BMI) >45 kg/m2
- Type 1 diabetes
- Haemostasis disorders or current treatment with anticoagulants
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.