Status:
COMPLETED
Study of Losartan in the Treatment of NAFLD in Children
Lead Sponsor:
Miriam Vos, MD
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Healthcare of Atlanta
Conditions:
NAFLD
Eligibility:
All Genders
11-19 years
Phase:
PHASE2
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of mortality and natur...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) \> 85th% for age and gender
- History of definite or borderline nonalcoholic steatohepatitis (NASH) diagnosed by liver biopsy using NASH Clinical Research Network (CRN) criteria
- At least 2 months of attempted lifestyle changes after liver biopsy
- Current ALT ≥ 3 times normal (69 U/L for girls, 78 U/L for boys) at enrollment
- Glomerular filtration rate (GRF) \> 90
- Weight ≥ 62.5 kg
Exclusion
- Other chronic illness requiring daily medication (except medications for mild mental illness, acid reflux, allergies, stable attention deficit hyperactivity disorder (ADHD), or asthma)
- Supplement or anti-oxidant therapy within past 2 weeks
- Renal insufficiency
- Cirrhosis and liver synthetic dysfunction (International Normalized Ratio ≥ 1.5)
- History of hypotension
- Diabetes (or fasting glucose \> 125 mg/dL)
- Acute illness within past 2 weeks prior to enrollment (fever \> 100.4ºF)
- Pregnancy
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01913470
Start Date
July 1 2013
End Date
December 1 2015
Last Update
May 15 2017
Active Locations (1)
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1
Emory University / Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322