Curcumin for non-alcoholic steatohepatitis (NASH)

Phase 2

Completed

• Conditions: onalcoholic steatohepatitis; Digestive System

• Registration Number: ISRCTN27793187
• Lead Sponsor: Ospedale Humanitas Gradenigo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-21
• Study Completion: 2022-12-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed
consent.
2. Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
3. Histologic evidence of NASH based on experienced pathologist evaluation of a liver biopsy obtained up to 4 weeks before screening.
4. A histological NAS = 4 with a score of 1 or more in each sub-component of the score based on
pathologist evaluation.
5. NASH fibrosis stage 1, 2, or 3 according to the NASH CRN fibrosis staging system

Exclusion Criteria

1. Refusal or lacks capacity to give informed consent to participate in the trial.
2. Participation in any clinical trial of an investigational therapy or agent within 12 months of randomisation.
3. Patient (or carer) deemed not competent at using the correct site and technique for subcutaneous injection of the trial treatment (containing
dummy drug on practice).
4. NAFLD Activity Score (NAS) <3 on liver biopsy.
5. Child’s B or C cirrhosis or clinical evidence of decompensated chronic liver disease: radiological or clinical evidence of ascites, current or previous hepatic
encephalopathy and evidence of portal hypertensive haemorrhage or varices on endoscopy.
6. Medical history of multiple drug allergies (defined as anaphylactoid drug reactions in >2 drug groups) or allegry to curry or curcumin-based nutraceuticals
7. Presence of any acute/chronic infections or illness that at the discretion of the chief investigator might compromise the patient’s health
and safety in the trial.
8. Pregnancy or breastfeeding.
9. Women, of childbearing age, who are not willing to practise effective contraception (ie, barrier, oral contraceptives, impenon or past
medical history of hysterectomy) for the 48-week duration of the trial and for 1 month after the last administration of the drug.
10. Liver disease of other aetiologies (ie, drug-induced, viral hepatitis, autoimmune hepatitis, PBC, PSC, haemochromatosis, A1AT deficiency, Wilsons disease).
11. Average alcohol consumption >20 g/d(males) and >10 g/d(females) (as assessed by a validated questionnaire(AUDIT-10) within the last 5 years.
12. Medical/surgery history of; gastric bypass surgery, orthotopic liver transplant (OLT) or listed for OLT, hepatocellular, pancreatic, thyroid carcinoma, acute or chronic pancreatitis and total parenteral nutrition within 6 months of randomisation.
13. Diagnosis of malignancy within the last 3 years (with the exception of treated skin malignancies).
14. Hepatocellular carcinoma: dysplastic or intermediate nodules to be excluded. Regenerative and other nodules to be included at the discretion of the chief investigator.
15. Alanine aminotransferase or aspartate aminotransferase >10×upper limit of normal.
16. >5% weight loss since the diagnostic liver biopsy was obtained.
17. Recent (within 3 months of the diagnostic liver biopsy or screening visit) or significant change (as judged by the chief investigator) in dose of the following drugs: inducers of hepatic steatosis (steroids (oral/intravenous), methotrexate, amiodarone), orlistat and/or multivitamins/
vitamin E (containing >200% recommended daily amount; >30 mg/day).
18. Known positivity for antibody to HIV.
19. Currently being treated with renal replacement therapy (ie, haemodialysis or peritoneal dialysis).

Specific exclusion criteria for participants with T2D
1. Participants receiving thiazolidinediones (TZDs), dipeptidy peptidase (DPP) IV inhibitors and other GLP-1-based therapies.
3. HbA1c =10%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histological NASH resolution measured using the NASH Clinical Research Network criteria) after 72 weeks. Liver biopsies will be read and scored by a single pathologist (RP), who will be blinded to patient clinical characteristics and treatment allocation.