Status:
UNKNOWN
Multicenter, Randomized, Controlled and Double-blind Study of Efficacy and Safety of Endoscopic Gastric Tubulization in Patients With Non-alcoholic Steatohepatitis (NASH-APOLLO).
Lead Sponsor:
Puerta de Hierro University Hospital
Collaborating Sponsors:
Hospital Universitario Ramon y Cajal
Hospital Universitario Marqués de Valdecilla
Conditions:
Non-Alcoholic Fatty Liver Disease
Obesity
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Nonalcoholic steatohepatitis is a growing public health problem affecting over 5% of the population. These patients are at increased risk of cardiovascular and liver-related death and have higher rate...
Eligibility Criteria
Inclusion
- Men or women aged between 18 and 75 years (inclusive) at the time of the first screening visit.
- They must provide signed written informed consent and agree to comply the study protocol
- Body mass index\> 30 kg / m².
- Histological confirmation of steatohepatitis in a diagnostic liver biopsy (biopsy obtained in the 6 months prior to randomization or during the selection period) with at least a score of 1 in each component of the NAS score (steatosis with a score of 0 to 3, degeneration by ballooning with a score of 0 to 2 and lobular inflammation with a score of 0 to 3) and fibrosis of 0 to \<4, according to the staging system of CRN fibrosis on NASH.
- NAS score ≥ 4.
- For patients without fibrosis or with stage 1 fibrosis, the NAS score≥5 and one of the following conditions (metabolic syndrome (definition NCEP ATP III), DM type II, HOMA-IR\> 6).
- The liver biopsy should have been done with a 16 G trucut needle and the minimum size should be 25 mm.
Exclusion
- Known heart failure (Grade I to IV of the classification of the New York Heart Association).
- History of effective bariatric surgery in the 5 years prior to selection.
- Patients with a history of clinically significant acute cardiac event in the 6 months prior to selection, such as: acute cardiovascular event, cerebrovascular accident, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
- Weight loss of more than 5% in the 6 months prior to randomization.
- Liver cirrhosis.
- Non-cirrhotic portal hypertension.
- Recent or current background of significant consumption of alcoholic beverages (\<5 years). In the case of men, significant consumption is usually defined as more than 30 g of pure alcohol per day. In the case of women, it is usually defined as more than 20 g of pure alcohol per day.
- Esophagogastric varices.
- Hepatocellular carcinoma
- Portal thrombosis.
- Pregnancy.
- Refusal to give informed consent.
- Any medical condition that could reduce life expectancy to less than 2 years, including known cancers.
- Signs of any other unstable or clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease without treatment.
- Instability or mental incompetence, so that the validity of the informed consent or the ability to comply with the study are uncertain.
- In addition to the above criteria, the patient must not present any of the following biological exclusion criteria:
- Antibodies positive for the human immunodeficiency virus.
- Aspartate aminotransferase (AST) and / or ALT\> 10 x upper limit of normal (ULN).
- Total bilirubin\> 25 μmol / l (1.5 mg / dl).
- Standardized international index\> 1.4.
- Platelet count \<100 000 / mm3.
- Serum creatinine levels\> 135 μmol / l (\> 1.53 mg / dl) in men and\> 110 μmol / l (\> 1.24 mg / dl) in women.
- Significant renal disease, including nephritic syndrome, chronic kidney disease (patients with markers of hepatic injury or estimated glomerular filtration rate \[eGFR\] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the eGFR measurement may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the expected randomization. An abnormal repeated eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03426111
Start Date
April 18 2018
End Date
December 1 2020
Last Update
December 12 2018
Active Locations (1)
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1
Jose Luis Calleja
Majadahonda, Madrid, Spain, 28222