Status:
COMPLETED
Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Non Alcoholic Steatohepatitis
Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, placebo-controlled phase 1/2a study to investigate the safety and tolerability of Idebenone in patients 18 years of age or older with non-alcoholic steatohepatitis, with stage 1-...
Detailed Description
This is a prospective phase 1/2a, randomized, double-blinded, placebo-controlled, single center study of safety and efficacy of oral idebenone in adults 18 years of age or older with non-alcoholic ste...
Eligibility Criteria
Inclusion
- 1\) Male or non-pregnant/ non-lactating women ≥ 18 years of age
- 2\) Diagnosis of NASH: NAFLD activity score (NAS) of 4 or greater with a score of 1 for each of the following (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2):
- Steatosis
- Lobular inflammation
- Hepatocyte ballooning 3) Fibrosis (Ishak fibrosis score ≥1 on liver biopsy) within 6 months of enrollment with MELD\<10, or based on MRE
Exclusion
- Presence of any other form of liver disease, including viral hepatitis, autoimmune hepatitis, alcoholic liver disease, genetic causes of chronic liver disease):
- Subjects with other etiologies of chronic liver disease, such as chronic hepatitis B and C; autoimmune hepatitis; and inherited liver disease.
- ALT\>300 U/l
- Total serum bilirubin ≥ to 1.3 mg/dL (Gilbert's Syndrome patients excepted)
- International Normalized Ratio (INR) ≥ 1.3
- MELD\>10
- Serum creatinine \>2.0mg/dl
- Known alcohol abuse or alcohol use disorder:
- \>20 g/day for women
- \>30 g/day for men
- Active substance abuse
- Any medical condition that prevents MRE, MR-PDFF
- Platelet count ≤100//mm3
- Decompensated cirrhosis
- Hemoglobin \<11 g/dl in females or \<12 g/dl in males
- Presence/history of HCC
- History of liver transplantation
- History of bariatric surgery
- History of inflammatory bowel disease
- History of cardiovascular disease, long QT syndrome.
- Subjects who have participated in investigational drug trials and took any investigational drugs within 60 days prior to the first dose of Idebenone. History of receiving other investigations drug within 30 days prior to enrollment
- Any concerns regarding compliance by enrolling physician
Key Trial Info
Start Date :
July 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04669158
Start Date
July 30 2021
End Date
July 5 2023
Last Update
September 23 2025
Active Locations (2)
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1
Digestive Health Center, Stanford University
Redwood City, California, United States, 94063
2
Stanford University
Stanford, California, United States, 94305