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Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension

NCT02960204 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2022-02-11

Study results available
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Summary

This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.

Conditions

  • Cirrhosis
  • Portal Hypertension
  • Non-alcoholic Steatohepatitis

Interventions

DRUG

Emricasan

DRUG

Placebo

Sponsors & Collaborators

  • Histogen

    lead INDUSTRY

Principal Investigators

  • Jeanette M Wetzel · Histogen

  • Samuel Mboggo · Histogen

  • Ruqayyah Abdulrahoof · Histogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-17
Primary Completion
2018-10-02
Completion
2019-04-08
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02960204 on ClinicalTrials.gov