E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Alcoholic Fatty Liver Disease in patients undergoing weight-loss (bariatric) surgery |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031743 |
E.1.2 | Term | Other chronic nonalcoholic liver disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To quantify the decrease in extent of hepatocellular damage and its clinical effect in NAC group as measured by: -
• Difference in liver function tests from before and after surgery, specifically AST and ALT as markers of hepatocellular damage (ALT is more specific to liver) • Extent of hepatocellular damage, as assessed by histopathological criteria • Decrease in post-operative morbidity and length of hospital stay
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E.2.2 | Secondary objectives of the trial |
To elucidate the mechanism by which NAC decreases hepatocellular damage using • Genetic (molecular biology) analysis • Serum biomarkers of inflammation, fibrosis, apoptosis and oxidative stress
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or Female Age range 18 to 75 years inclusive Patients must meet the criteria set out by NICE for morbid obesity surgery, that is they must have BMI >40kg/m2 or >35kg/m2 with obesity-related complications, and are undergoing either Laparoscopic Adjustable Gastric Banding or Roux-en-Y Gastric Bypass or Laparoscopic Sleeve Gastrectomy
Fully informed, written consent obtained prior to enrolment into this study.
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E.4 | Principal exclusion criteria |
Patients undergoing Duodenal Switch Patients undergoing OPEN bariatric surgery (a small minority of total patients) Pregnancy History of chronic liver disease, including viral hepatitis, haemochromatosis, alcoholic liver disease or known alcohol intake > 28 units per week Previous liver surgery, eg resection, orthotopic transplantation History of active psychiatric illness, including severe depression, bipolar disorder, schizophrenia and eating disorders Bleeding tendency or anticoagulant medications Known allergies to N-acetylcysteine or related compounds
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E.5 End points |
E.5.1 | Primary end point(s) |
• Difference in liver function tests from before and after surgery, specifically AST and ALT as markers of hepatocellular damage (ALT is more specific to liver) • Extent of hepatocellular damage, as assessed by histopathological criteria • Decrease in post-operative morbidity and length of hospital stay
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of Trial occurs with the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |