Status:
WITHDRAWN
The Effect of Acetaminophen on Non-alcoholic Fatty Liver Disease Patients
Lead Sponsor:
University of Southern California
Conditions:
Non-alcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
In this first pilot study, we will examine the effects of acetaminophen dosing in adult patients with NAFLD in comparison to the effects in a healthy control group. Both groups will receive 3 grams (g...
Eligibility Criteria
Inclusion
- NAFLD patients:
- Inclusion criteria:
- "Presence of NAFLD": This will be defined by the presence of at least two of the following criteria: (a) suggestion of liver fat by an imaging study (ultrasound, CT scan, MRI or MR spectroscopy) performed in the 6 months prior to enrollment; (b) elevated aminotransferase levels (ALT \> 31 U/L for men or \> 19 U/L for women, or AST \> 30 U/L) on at least two occasions in the 6 months preceding enrollment; and (c) presence of the metabolic syndrome, defined according to the modified AHA/NCEP criteria. Biopsies are not required; however, previous biopsy done within the 6 months prior to the initiation of the study will be considered diagnostic if typical findings of NAFLD are described and other causes of liver disease are ruled out;
- Individuals who are 18-70 years old;
- Written informed consent.
- Exclusion criteria:
- Serum ALT \> 3 times ULN at baseline.
- Evidence of another form of liver disease including viral hepatitis, autoimmune hepatitis, cholestatic liver disease, Wilson's disease, Alpha-1-antitrypsin deficiency, hemochromatosis or DILI.
- History of excess alcohol ingestion, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1 drink per day: 7 drinks per week) in the previous one year.
- Evidence of liver cirrhosis on labs or imaging.
- History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis in the previous 6 months.
- Significant systemic or major illnesses other than liver disease.
- Positive test for anti-HIV.
- Active substance abuse.
- Pregnancy or inability to practice adequate contraception in women of childbearing potential
- Evidence of hepatocellular carcinoma.
- Any other condition which, in the opinion of the investigators, would impede competence or compliance.
- Serum creatinine \>1.5 mg/dl.
- Starting medications that have been shown to cause drug induced liver injury (eg, augmentin, statins.) within one month prior to enrollment. Medications that have been known to cause DILI but have taken for more than one month prior to enrollment (such as statins) should not be an exclusion.
- Healthy Controls:
- Inclusion criteria:
- Individuals who are 18-70 years old
- Normal Liver enzymes
- Negative hepatitis B surface antigen, and hepatitis C antibody
- BMI (18.5 - 24.9) kg/m2
- Written informed consent.
- Exclusion criteria:
- Presence of the metabolic syndrome, defined according to the modified AHA/NCEP criteria
- Taking concomitant medications
Exclusion
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02194894
Start Date
June 1 2014
End Date
March 19 2015
Last Update
March 30 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
USC
Los Angeles, California, United States, 90033
2
USC HCC II (Fatty Liver Clinic)
Los Angeles, California, United States, 91105