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New treatment option for NAFLD
Official title Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD
ClinicalTrials.gov ID: NCT04681573
What this study is testing
- What it's testing
- NAFLD, closely linked to overweight and insulin resistance, has reached 25% prevalence worldwide. Advanced liver fibrosis(ALF) must be accurately diagnosed in NAFLD because it defines a subgroup of patients with impaired prognosis, and these patients need a specific management to prevent the occurrence of liver-related complication.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Presence of NAFLD as defined by :
- The presence of liver steatosis as assessed by ultrasonography (bright liver) or magnetic resonance imaging/spectroscopy (fat fraction \>5.6%) or...
- The absence of steatosis-inducing drugs (systemic corticosteroids, methotrexate, amiodarone, tamoxifen)
- The absence of excessive alcohol consumption (\<210 g/week in men or \<140 g/week in women)
- The absence of other causes of chronic liver disease (chronic viral hepatitis B or C, hemochromatosis, auto-immune hepatitis, primary biliary...
You likely can't join if
- Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
- Hepatocellular carcinoma
- Inability to safely undergo liver biopsy
- Participation in other intervention study with drug protocol treatment in progress at the time of inclusion or within one month prior to inclusion in...
- Pregnant, breastfeeding or parturient woman
- Person restricted by judicial or administrative decision
See the full eligibility criteria
- Presence of NAFLD as defined by :
- The presence of liver steatosis as assessed by ultrasonography (bright liver) or magnetic resonance imaging/spectroscopy (fat fraction \>5.6%) or Controlled Attenuation Parameter (≥248 dB/m)
- The absence of steatosis-inducing drugs (systemic corticosteroids, methotrexate, amiodarone, tamoxifen)
- The absence of excessive alcohol consumption (\<210 g/week in men or \<140 g/week in women)
- The absence of other causes of chronic liver disease (chronic viral hepatitis B or C, hemochromatosis, auto-immune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease...
- Age ≥18 years and ≤80 years
- Affiliated person or beneficiary of a social security regime
- Written informed consent of the patient who agree to comply with the study protocol.
- Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
- Hepatocellular carcinoma
- Inability to safely undergo liver biopsy
- Participation in other intervention study with drug protocol treatment in progress at the time of inclusion or within one month prior to inclusion in the study.
- Pregnant, breastfeeding or parturient woman
- Person restricted by judicial or administrative decision
- Person under psychiatric care under restraint
- Person subject to a legal protection measure
- Person unable to express consent
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Besançon, France
- Bobigny, France
- Dijon, France
- La Roche-sur-Yon, France
- La Tronche, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Pessac, France
- Rennes, France
- Tours, France
- Vandœuvre-lès-Nancy, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Besançon, France; Bobigny, France; Dijon, France; La Roche-sur-Yon, France; La Tronche, France and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.