ACTRN12621001710819RecruitingPhase 2
A Randomised, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Sublingual TransT3-60 in the Treatment of Non-Alcoholic SteatoHepatitis (NASH)
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Invictus Ops Pty Ltd
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1. Age greater than 18 years.
- •2. Patients will be selected by investigators as likely to have NASH but not cirrhosis, based on the patient’s history, physical examination, imaging and laboratory tests or incidental recent liver biopsy.
- •3. MRI-PDFF hepatic fat fraction should be >8%.
- •4. Fibroscan score should indicate NASH and not cirrhosis.
- •5. Participant must read and understand the informed consent form and must have signed it prior to any study-related procedures being performed.
- •6. Willingness and ability to comply with all scheduled study visits and study procedures.
Exclusion Criteria
- •1. Chronic hepatitis B and C. Patients who are HCV PCR negative and have been negative for at least 12 months may be included. Patients with HBV on antiviral therapy with a HBV DNA <20 IU/mL for at least 6 months may be included.
- •2. HIV antibody positive.
- •3. Concomitant liver disease such as autoimmune hepatitis, primary biliary cirrhosis and Wilson’s disease.
- •4. Decompensated advanced liver disease and cirrhosis.
- •5. Treatment with medications known to cause fatty liver such as methotrexate, atypical neuroleptics and tamoxifen.
- •6. Uncontrolled hypo or hyperthyroidism.
- •7. Uncontrolled diabetes, HBA1c >9.
- •8. Active coronary artery disease defined as persisting angina.
- •9. Chronic kidney disease with an eGFR<60mL/min.
- •10. Platelet count<100,000/mm3, INR>1.3, ALT>5XULN.
- •11. Alcohol use >20g/day or substance abuse in the last 12 months.
- •12. Treatment with insulin sensitisers such as glitazones.
- •13. Treatment with silymarin (milk thistle).
- •14. Treatment with vitamin E (tocopherol) in the 4 weeks prior to study entry and for the duration of study participation.
- •15. Patients who are unable or unwilling to comply with the protocol requirements.
- •16. Women who are pregnant or lactating at the time of Randomisation.
- •17. Participation in any investigational study within 8 weeks of screening visit.
- •18. Participant has any other medical condition that, in the opinion of the investigator and/or medical monitor, would make the participant unsuitable for the study.
Investigators
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