IRCT20200128046294N1
Not yet recruiting
Phase 3
A Prospective Randomized Controlled Trial Comparing Three Advanced Therapies in the Treatment of Non-Alcoholic Steatohepatitis
Dr. Abidi Pharmaceuticals0 sites105 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr. Abidi Pharmaceuticals
- Enrollment
- 105
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is a candidate for general anesthesia
- •Is eligible for bariatric surgery (SG)
- •Is \=18 and \=65 years old
- •Have a BMI \=30 and \=45 kg/m2
- •Have a platelet count \>150,000 and International Normalized Ratio (INR) \=1\.2
- •Have appropriate composite entry criteria on liver biopsy: NAFLD with activity score between 4 and 8, presence of hepatocyte ballooning, and fibrosis stage between 1 and 3, confirmed by independent reviews by 3 liver pathologists. In case of any discrepancies in histopathologic report, a joint review by 3 study pathologists will be performed.
- •Have the ability and willingness to participate in the study and agree to any of the arms involved in the study.
- •Able to understand the options and to comply with the requirements of each arm.
- •Have a negative urine pregnancy test at screening and randomization visits for women of childbearing potential.
- •Women, of childbearing age, must agree to use reliable method of contraception for 1 year.
Exclusion Criteria
- •1\.Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic): a.Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg), b.Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA, c.Autoimmune liver disease as diagnosed by antibodies and compatible liver histology, d.Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti\-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts), e.Primary sclerosing cholangitis, f.Wilson’s disease as diagnosed by low ceruloplasmin and compatible liver histology, g.Alpha\-1\-antitrypsin deficiency as diagnosed by alpha1\-antitrypsin level and liver histology, h.Hemochromatosis as diagnosed by presence of 3\+ or 4\+ stainable iron on liver biopsy, i.Drug\-induced liver disease as diagnosed by medical history, j.Known bile duct obstruction, k.Suspected or proven liver cancer
- •Type 1 diabetes or autoimmune diabetes
- •Known cases of human immunodeficiency virus infection
- •Prior bariatric surgery of any kind
- •Prior complex foregut surgery including any esophageal and gastric surgeries, anti\-reflux procedures, splenectomy, biliary diversion, and trauma
- •Thoracic, abdominal, pelvic and/or obstetric\-gynecologic surgery within 6 months
- •Any other surgery requiring general anesthesia within 6 weeks prior to signing the consent
- •American Society of Anesthesiologists Class IV or V
- •History of solid organ transplant
- •Severe pulmonary disease defined as FEV1 \< 50% of predicted value
Outcomes
Primary Outcomes
Not specified
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