Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
83 participants
INTERVENTIONAL
2018-10-02
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Losartan potassium capsule
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to \<150 kg.
Losartan potassium
Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
Placebo losartan capsule
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to \<150 kg.
Placebo losartan capsule
Matching placebo losartan oral capsule
Interventions
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Losartan potassium
Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
Placebo losartan capsule
Matching placebo losartan oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological evidence of NAFLD with or without fibrosis and a NAFLD activity score (NAS) of ≥3, on a liver biopsy obtained no more than 730 days prior to enrollment.
* Serum ALT at screening ≥ 50 IU/L
Exclusion Criteria
* Significant alcohol consumption or inability to reliably quantify alcohol intake
* Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 consecutive weeks in the past year prior to randomization
* New treatment with vitamin E or metformin started in the past 90 days or plans to alter the dose or stop over the next the 24 weeks. A stable dose is acceptable.
* Prior or planned bariatric surgery
* Uncontrolled diabetes (HbA1c 9.5% or higher)
* Presence of cirrhosis on liver biopsy
* History of hypotension or history of orthostatic hypotension
* Stage 2 Hypertension or \>140 systolic or \>90 diastolic at screening
* Current treatment with any antihypertensive medications including all angiotensin converting enzyme (ACE) inhibitors or aliskiren
* Current treatment with potassium supplements or any drug known to increase potassium
* Current daily use of nonsteroidal anti-inflammatory drugs (NSAIDs)
* Current treatment with lithium
* Platelet counts below 100,000 /mm3
* Clinical evidence of hepatic decompensation (serum albumin \< 3.2 g/dL, international normalized ratio (INR) \>1.3, direct bilirubin \>1.3 mg/dL, history of esophageal varices, ascites, or hepatic encephalopathy)
* Evidence of chronic liver disease other than NAFLD:
* Biopsy consistent with histological evidence of autoimmune hepatitis
* Serum hepatitis B surface antigen (HBsAg) positive.
* Serum hepatitis C antibody (anti-HCV) positive.
* Iron/total iron binding capacity (TIBC) ratio (transferrin saturation) \> 45% with histological evidence of iron overload
* Alpha-1-antitrypsin (A1AT) phenotype/genotype ZZ or SZ
* Wilson's disease
* Serum alanine aminotransferase (ALT) greater than 300 IU/L
* History of biliary diversion
* History of kidney disease and/or estimated glomerular filtration rate (eGFR) \< than 60 mL/min/1.73 m2 using Schwartz Bedside GFR Calculator for Children isotope dilution mass spectroscopy (IDMS)-traceable
* Known Human Immunodeficiency Virus (HIV) infection
* Active, serious medical disease with life expectancy less than 5 years
* Active substance abuse including inhaled or injected drugs, in the year prior to screening
* Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding
* Participation in an investigational new drug (IND) trial in the 150 days prior to randomization
* Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study
* Inability to swallow capsules
* Known allergy to losartan potassium or other angiotensin receptor blocker
* Failure of parent or legal guardian to give informed consent or subject to give informed assent
8 Years
17 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Edward Doo, MD
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
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University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern Univ-Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
St. Louis University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Parental Permission Form
Document Type: Informed Consent Form: Child Assent Form
Document Type: Informed Consent Form: HIPAA Authorization Form
Related Links
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Nonalcoholic Steatohepatitis Clinical Research Network Centers
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Other Identifiers
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9 STOP-NAFLD
Identifier Type: -
Identifier Source: org_study_id