A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Nonalcoholic Steatohepatitis (nash)
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Age: Between 18 Year(s) - 100 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Must be willing to participate in the study and provide written informed consent
- Male and female adults =18 years of age
- Clinical diagnosis of NASH Cirrhosis
- Female patients who:
a) are of reproductive potential and have a negative serum pregnancy test, are not breastfeeding, and do not plan to become pregnant during the study and agree to use 2 highly effective birth control methods during the study
b) OR are not of child bearing potential (ie, surgically [bilateral oophorectomy, hysterectomy, or tubal ligation] or naturally sterile [>12 consecutive months without menses]) - Male patients who are sexually active with a partner of child-bearing potential and:
a) are sterile (vasectomy with history of a negative sperm count at least 90 days following the procedure)
b) OR practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable) OR
c) OR use a male condom with any sexual activity;
d) OR agree to use a birth control method - No history of a hepatic decompensation event
You may not be eligible for this study if the following are true:
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- Chronic liver diseases other than NASH cirrhosis:
a) Primary biliary cholangitis
b)Primary sclerosing cholangitis
c) Hepatitis B positive
d) Hepatitis C
e) History or evidence of current active autoimmune hepatitis
f)History or evidence of Wilson's disease
g)History or evidence of alpha-1-antitrypsin deficiency
h) History or evidence of genetic hemochromatosis (hereditary, primary)
i)Evidence of drug-induced liver disease, as defined on the basis of typical exposure and history
j) Known bile duct obstruction
k) Suspected or confirmed liver cancer - History of hepatic decompensation or impairment
- Diagnosis of hepatocellular carcinoma (HCC)
- Thyroid diseases, as defined by the following conditions:
a)Active hyperthyroidism
b) Untreated clinical hypothyroidism - Has an active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease, or autoimmune hepatitis that requires systemic treatment within the past 12 weeks or a documented history of clinically severe autoimmune disease, including autoimmune liver disease, or a syndrome that requires systemic steroids or immunosuppressive agents
- Alcohol consumption of any type, frequency or amount is not allowed during the Screening or Treatment phase of the study
- History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study
- History of biliary diversion
- Uncontrolled hypertension (either treated or untreated)
- New York Heart Association Class III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Myocardial infarction, unstable angina, emergent percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months
- Use of statin therapy exceeding the following doses is not allowed:
a)Atorvastatin >20 mg daily
b) Rosuvastatin >20 mg daily
c) Simvastatin >20 mg daily
d) Pravastatin >40 mg daily
e) Lovastatin >20 mg daily
f) Pitavastatin >2 mg daily - Use of high dose vitamin E (>400 IU/day) unless stable for =6 months prior to randomization. Vitamin E can be discontinued or decreased but dose cannot be increased during the study
- Use of pioglitazone >15 mg per day
- Regular use of drugs historically associated with NAFLD, which include, but are not limited to, the following: amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids except testosterone replacement, valproic acid, and known hepatotoxins for more than 4 weeks within the last 8 weeks prior to the initial Screening
- Use of illicit drugs within 5 years prior to randomization or a urine drug screen result positive for amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, or phencyclidine at Screening, unless a prescribed drug accounts for the positive test
- Active, serious medical disease other than NASH cirrhosis with a likely life expectancy
- Participation in an investigational new drug trial (non-NASH therapeutic) in the last 60 days
- Prior treatment with NASH therapeutics in an investigational trial
- History of major surgery (ie, surgery involving a risk to the life of the patient; specifically, an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity) within 6 weeks prior to randomization
- History of cancer within the last 5 years (other than treated and believed to be cured basal or squamous cell carcinoma of the skin or resected carcinoma of the cervix)
- Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, who are known to be positive for human immunodeficiency virus (HIV), or who have recurrent or chronic systemic bacterial, fungal, viral, or protozoal infections <5 years
- Chronic liver diseases other than NASH cirrhosis:
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.