Safety And Efficacy Of Simtuzumab (GS-6624) In Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary To Non-Alcoholic Steatohepatitis (NASH)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 12-009480
NCT ID: NCT01672866
Sponsor Protocol Number: GS-US-321-0105
About this study
This study will evaluate whether simtuzumab (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with non-alcoholic steatohepatitis (NASH). It will consist of 2 phases: - Randomized Double-Blind Phase - Open Label Phase (optional)
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Key Inclusion Criteria:
- Adults with chronic liver disease due to NASH defined as macrovesicular steatosis involving > 5% of hepatocytes on a liver biopsy with associated lobular inflammation
- Stage 3-4 fibrosis by Ishak score on a liver biopsy
- Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
- Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x Central Laboratory Upper Limit of Normal (clULN)
- Must have serum creatinine < 2.0 mg/dL
- A negative serum pregnancy test is required for females of childbearing potential
- All sexually active females of childbearing potential must agree to use a protocol recommended method of contraception during intercourse throughout the study and for 90 days following the last dose of study medication
- Lactating females must agree to discontinue nursing before starting study treatment
- Males, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from the screening through the study completion and for 90 days following the last dose of study drug.
Key Exclusion Criteria:
- Pregnant or breast feeding
- Cirrhosis of the liver
- Any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
- Weight reduction surgery in the past 5 years
- Positive for hepatitis C virus (HCV) RNA
- Positive for HBsAg
- Alcohol consumption greater than 21oz/week for males or 14oz/week for females
- Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening.
- Clinically significant cardiac disease
- History of malignancy, other than non-melanomatous skin cancer, within 5 years prior to screening
- Major surgical procedure within 30 days prior to screening or the presence of an open wound
- Known hypersensitivity to the investigation product or any of its formulation excipients
- History of bleeding diathesis within 6 months of screening
- Unavailable for follow-up assessment or concern for individual's compliance with the protocol procedures;
- Participation in an investigational trial of a drug or device within 30 days prior to screening
- BMI < 18 kg/m^2
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Bashar Aqel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available