Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)
Lead Sponsor:
Gilead Sciences
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 fibro...
Detailed Description
This is a Phase 2, randomized, double-blind, parallel group, placebo controlled, multicenter study investigating the safety, tolerability, pharmacokinetics and activity of multiple oral doses of GS 94...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00740610
Start Date
August 1 2008
End Date
September 1 2009
Last Update
February 4 2014
Active Locations (33)
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1
Tucson, Arizona, United States
2
Fresno, California, United States
3
Fullerton, California, United States
4
San Diego, California, United States, 92161