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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis. - REVERSE

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000474-11-ES

Enrollment

540

Registered

2018-04-20

Start date

2018-06-29

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compensated Cirrhosis due to Nonalcoholic Steatohepatitis

Interventions

Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA Ot

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 =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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effects of OCA treatment compared with placebo on improvement in fibrosis by at least 1 stage with no worsening of Nonalcoholic Steatohepatitis (NASH), using the NASH Clinical Research Network (CRN) scoring system.;Secondary Objective: To evaluate the effects of OCA treatment compared with placebo on improvement in fibrosis by at least 2 stages using Ishak scoring criteria and resolution of NASH using the NASH CRN scoring system.;Primary end point(s): Improvement in fibrosis by at least 1 stage with no worsening of NASH, using NASH CRN scoring system.;Timepoint(s) of evaluation of this end point: Baseline to Month 12	—

Measure

Time frame

Main Objective: To evaluate the effects of OCA treatment compared with placebo on improvement in fibrosis by at least 1 stage with no worsening of Nonalcoholic Steatohepatitis (NASH), using the NASH Clinical Research Network (CRN) scoring system.;Secondary Objective: To evaluate the effects of OCA treatment compared with placebo on improvement in fibrosis by at least 2 stages using Ishak scoring criteria and resolution of NASH using the NASH CRN scoring system.;Primary end point(s): Improvement in fibrosis by at least 1 stage with no worsening of NASH, using NASH CRN scoring system.;Timepoint(s) of evaluation of this end point: Baseline to Month 12

—

Secondary

Measure	Time frame
Secondary end point(s): Improvement in fibrosis by at least 2 stages using the Ishak scoring criteria and NASH resolution using the NASH CRN scoring;Timepoint(s) of evaluation of this end point: Baseline to Month 12	—

Countries

Australia, Canada, France, Germany, New Zealand, Spain, United Kingdom, United States

Contacts

Public ContactNichole Godding

INC Research

nichole.godding@syneoshealth.com0034916307447

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026