MATCH

Phase 1

• Conditions: iver Cirrhosis; MedDRA version: 20.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-000963-15-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-02
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

INCLUSION CRITERIA

1. 18= AGE =75 at screening

2. Aetiology: one or more of:

•Alcohol Related Liver Disease (ALD)
No active alcohol misuse =6 calendar months prior to screening. Features of chronic liver disease with a compatible history of alcohol excess (>80g/day), in the absence of other causes of chronic liver disease. Participants with other aetiologies of liver disease may drink alcohol within current recommended limits (14 units per week for females and for males)

•Primary Biliary Cirrhosis (PBC)
2 out of:
Cholestatic LFTs
Positive AMA (>1:40)
Compatible Histology

If already receiving Ursodeoxycholic Acid must be established on current dose >3 months prior to enrolment

•Non-Alcoholic Fatty Liver Disease (NAFLD)

Either:
Histological evidence of steatosis in the absence of other liver diseases
Or:
Imaging compatible with NAFLD (eg Fatty infiltration of liver) and one or more risk factors (e.g. elevated BMI, T2DM, Hypertriglyceridaemia, Hypertension)
And:

The absence of significant alcohol consumption (<20g/day) and no evidence of other causes of chronic liver disease

•Cryptogenic cirrhosis

Diagnosis of cirrhosis unattributable to any other cause

•Haemochromatosis

Diagnosis made on basis of compatible Biochemistry (Transferrin Sat >60%, Ferritin >400), Genotype (Homozygous C282Y or H63D, Compound Heterozygote) or Histology

•Alpha-1 anti-trypsin deficiency

Diagnosis based on compatible genetic, phenotypic or histological testing.

•Previous Hepatitis C (sustained viral response ie. undetectable HCV RNA 24 weeks after completion of treatment.)

3. Diagnosis of Cirrhosis – invasive or non-invasive;

Cirrhosis, defined as one of:

•Previous liver biopsy confirming histological features of cirrhosis

•Transient Elastography (Fibroscan) >15 kPa

• Clinical and radiological features that in the opinion of the investigator correlate with a diagnosis of cirrhosis

4. 10>/MELD score
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

EXCLUSION CRITERIA

•Refusal or inability to give informed consent to participate in the study

•Other cause of chronic liver disease / cirrhosis not included in listed aetiologies – this is left to the clinical judgement of the investigator based on previous investigations and trial screening

•Portal Hypertensive Bleeding; active episode of bleeding requiring hospitalisation in the last 3 months

•Ascites unless, in the opinion of the investigator, the ascites is minimal and well controlled with no increase to diuretic therapy in last 3 months

•Encephalopathy; current or requiring hospitalisation for treatment in last 3 months

•Hepatocellular Carcinoma – uncertain cases to be discussed at local hepatobiliary Multidisciplinary meeting, dysplastic or indeterminate nodules to be excluded, regenerative or other nodules to be included at discretion of MDM

•Previous diagnosis of Hepatocellular Carcinoma

•Previous organ Transplant or previous recipient of tissue

•Listed for Liver Transplantation

•Any situation that in the Investigators opinion may interfere with optimal study participation such as alcohol or drug abuse, domicile too distant from study site, potential non-compliance or inability to co-operate

•Presence of clinically relevant acute illness that in the opinion of the investigator might compromise the participant’s safe participation in the study

•Presence or history of cancer within past 5 years with exception of adequately treated localised skin carcinoma, in situ cervical cancer or solid malignancy surgically excised in total without recurrence for 5 years

•Pregnancy or Breastfeeding

•Allergy to steroids

- Active infection on the mandatory microbiology blood tests
- Immunosuppressants eg Azathioprine
- Current enrolment in an interventional study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified