A clinical trial where neither the doctor, patient or sponsor know whether a placebo or active medicine is being given to the patient with compensated cirrhosis due to nonalcoholic steatohepatitis to see if the medicine is effective and safe in the treatment of that disease

Phase 1

• Conditions: Compensated Cirrhosis due to Nonalcoholic Steatohepatitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-000474-11-ES
• Lead Sponsor: Intercept Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-20
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. Current or past history of hepatic decompensation such as clinically significant ascites, hepatic encephalopathy (HE), or variceal bleeding.
2. Current or past history of CP score >=7 points
3. MELD score >12
4. ALT >=5× ULN
5. Calculated creatinine clearance <60 mL/min using Cockcroft-Gault method
6. Hemoglobin A1c >=9.5%
7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, Alpha-1-antitrypsin deficiency, drug-induced liver injury, Known or suspected HCC
8. History of liver transplant, current placement on a liver transplant list

Study & Design

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