Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis

In brief

The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH).

Key facts

Study ID

NCT00740610

Run by

Gilead Sciences

People needed

124

Starts

2008-08-01

Expected to finish

2009-09-01

Last updated by the study team

2014-02-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-75 years of age
• ALT > 60 U/L
• fatty liver on screening ultrasound
• and biopsy-confirmed NASH
• platelet count >/= 75,000/mm3 and adequate hematologic function (absolute neutrophil count >/= 1,500/mm3, hemoglobin >/= 11.0 g/dL)
• calculated creatinine clearance >/= 70 mL/min
• non-insulin dependent diabetes for < 10 years is allowed if stably managed for at least 6 months prior to screening
• stable weight (no weight loss > 4%) for 8 weeks prior to screening and should maintain consistent diet, food intake, and physical exercise during the study
• must have been on stable therapy for at least 3 months prior to screening if receiving 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors, niacin, fibrates, vitamin E or angiotensin receptor blockers
• must have been on a stable treatment regimen for at least 3 months prior to screening if receiving other drugs possibly associated with hepatic adverse events (e.g., isoniazid, itraconazole, ketoconazole, rifabutin, rifampin, and other agents with significant hepatotoxic potential)

You may not qualify if…

• Insulin dependent diabetes mellitus, treatment with sulfonylureas (may be allowed pending results from a drug-drug interaction study), subjects receiving glitazones at screening or within 6 months of screening, presence of diabetic peripheral neuropathy or gastroparesis
• A > 4% decrease in weight within 8 weeks of screening
• cirrhosis or decompensated liver disease (defined as conjugated bilirubin > 1.5 x the upper limit of the normal range (ULN), prothrombin time > 1.5 x ULN, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation
• presence of other form of liver disease other than NASH
• history of excess alcohol ingestion, averaging > 3 drinks/day in the previous 2 years; or current alcohol intake averaging > 2 drinks/day for females and > 3 drinks per day for males; history of or current binge drinking
• serological evidence of co-infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV
• evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/mL)
• history of ingesting drugs possibly associated with hepatic steatosis within the past year
• history of total parenteral nutrition within the past 6 months
• prior history of gastroplasty, jejunoileal, or jejunocolonic bypass surgery
• history of ingesting drugs within the past 3 months that may improve NASH and associated fibrosis
• significant gastrointestinal disease that would interfere with absorption of oral medications; inflammatory bowel disease
• major surgery within the past year
• clinically significant abnormalities on ECG or other ECG findings that the investigator considers a safety risk
• significant systemic or major illnesses other than liver disease that, in the opinion of the investigator, would preclude treatment and adequate follow up
• prior or current malignancy involving any organ system and skin cancer (previously excised basal cell carcinoma allowed)
• acute ongoing infection, or symptoms of infection
• pregnant or breastfeeding females
• acute substance abuse within the past year.
• history of ingesting anti-TNFα drugs or immunomodulators within the past 3 months

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Fresno, California, United States
• Study site — Fullerton, California, United States
• Study site — San Diego, California, United States
• Study site — San Mateo, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Monroe, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — New York, New York, United States
• Study site — Plainview, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Clevleand, Ohio, United States
• Study site — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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