Clinical Trials
OVERVIEW
The Division of Gastroenterology and Hepatology conducts clinical trials on novel therapeutics for various liver diseases, bringing promising and innovative therapies to our patients.
Our team has extensive experience selecting the right patients for the right trials.
Clinical trials are an important part of the research involved in developing new medical treatments. Enrolling in a clinical trial enables participants to take an active role in their own health care, gain entrance to new research, and contribute to medical science.
Participants must meet specific criteria to be eligible for enrollment in a clinical trial. Some research studies seek participants with illnesses or specific conditions to be studied in the clinicaltrial, while others ask for healthy participants.
CURRENT AND ONGOING TRIALS
Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis
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 1-3 fibrosis. As secondary end point target engagement and fibrosis improvement will be assessed.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Idebenone
- drug: Placebo
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Smart
650-725-8517
Not Recruiting