Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis (NCT04669158) | Clinical Trial Compass
CompletedPhase 1/2
Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis
United States53 participantsStarted 2021-07-30
Plain-language 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 1-3 fibrosis. As secondary end point target engagement and fibrosis improvement will be assessed.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0