Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/31/2019 |
Start Date: | October 26, 2016 |
End Date: | January 9, 2018 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in
participants with nonalcoholic steatohepatitis (NASH).
participants with nonalcoholic steatohepatitis (NASH).
Key Inclusion Criteria:
- Meets the following conditions:
- A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
- Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF)
with ≥ 8% steatosis
- Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5
kilopascal (kPa) OR
- A historical liver biopsy within 12 months of screening consistent with NASH with
fibrosis, but not cirrhosis, and
- No documented weight loss > 5% between the date of the liver biopsy and
screening.
- Platelet count ≥ 150,000/mm^3
- Albumin ≥ 3.3 g/dL
- Serum creatinine ≤ upper limit of normal (ULN)
Key Exclusion Criteria:
- Pregnant or lactating females
- Alanine aminotransferase (ALT) > 5x upper limit of the normal range (ULN)
- Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
- Cirrhosis of the liver
- Prior history of decompensated liver disease, including ascites, hepatic
encephalopathy, or variceal bleeding
- Body mass index (BMI) < 18 kg/m^2
- Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)
- International normalized ratio (INR) > 1.2 unless on anticoagulant therapy
- Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
27
sites
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
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Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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675 North Saint Clair Street
Chicago, Illinois 60611
Chicago, Illinois 60611
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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5801 Bremo Road
Newport News, Virginia 23226
Newport News, Virginia 23226
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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5801 Bremo Road
Richmond, Virginia 23226
Richmond, Virginia 23226
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