NCT06918080Active, not recruitingPhase 4
Hepatoprotective Measures for Children at High Risk of NAFLD
Hepatoprotective Measures for Children at High Risk of Non Alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 9 Apr 2025
Brief summary (registry, in English)
Non Alcoholic Fatty Liver Disease (NAFLD) is a spectrum of disease, ranging from simple fatty deposition (steatosis) to inflammation (steatohepatitis), fibrosis, cirrhosis, and end-stage liver failure. In childhood, it may be associated with a metabolic syndrome or with obesity, or even in normal children. Liver biopsy has always been the gold standard method for diagnosing and staging NAFLD. However, the urge of non-invasive biomarkers or imaging techniques has been recommended. This study will evaluate the use of the LIVERFASt biomarkers for early detection and staging of NAFLD.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- 19 Nov 2023
- Primary completion date
- May 2025
- Lead sponsor
- Ain Shams University
- NCT number
- NCT06918080
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 19 Nov 2023 to the primary completion date, May 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Conditions that could interfere with measured labs (acute/chronic hemolysis, acute hepatitis, extra hepatic cholestasis, systemic inflammatory response).
Who the study is looking for
- Children aged between 5-18 years, including:
- Population P1: N=65 overweight (BMI between 85th \& 94th centile) and obese children (BMI = or \> 95th centile) at-risk of NAFLD
- Population P2: N=65 children on maintenance therapy (High Dose Methotrexate 2.5 or 5 mg according to risk level, every other week for 4 doses and daily 6-Mercaptopurine tab. 50 mg/m2/day for 56 days) for Acute Lymphoblastic Leukemia, at risk of chemotherapy induced steatohepatitis.
- Population P3: N=65 control healthy children matched for gender and age with P1\&2.
Age in the registry: 5 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC) Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
| Ain Shams University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.