Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Purpose

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

Conditions

  • Compensated Cirrhosis
  • Nonalcoholic Steatohepatitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading

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. Model for End-stage Liver Disease (MELD) score > 12
  4. ALT ≥ 5 X ULN
  5. Calculated creatinine clearance <60mL/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 hepatocellular carcinoma (HCC)
  8. History of liver transplant, or current placement on a liver transplant list

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Obeticholic Acid (OCA) 10 mg
10 mg OCA for up to 12 months
  • Drug: Obeticholic acid (10 mg)
    Tablets administered orally once daily.
    Other names:
    • OCA
    • 6alpha-ethylchenodeoxycholic acid (6-ECDCA)
    • INT-747
  • Drug: Obeticholic acid (10 mg to 25 mg)
    Tablets administered orally once daily.
    Other names:
    • OCA
    • 6alpha-ethylchenodeoxycholic acid (6-ECDCA)
    • INT-747
Experimental
Obeticholic Acid (OCA) 10 mg to 25 mg
10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 9 months of the study
  • Drug: Obeticholic acid (10 mg to 25 mg)
    Tablets administered orally once daily.
    Other names:
    • OCA
    • 6alpha-ethylchenodeoxycholic acid (6-ECDCA)
    • INT-747
Placebo Comparator
Placebo
Placebo for up to 12 months
  • Drug: Placebo
    Tablets administered orally once daily.

Recruiting Locations

Tulane University Health Sciences Center
New Orleans, Louisiana 70112
Contact:
Delainna Bartholomew
504-988-6902
dbartho@tulane.edu

More Details

NCT ID
NCT03439254
Status
Recruiting
Sponsor
Intercept Pharmaceuticals

Study Contact

Stefanie Andrews
1-619-541-7448
stefanie.andrews@interceptpharma.com