MedTrace Logo

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

NCT01966419 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2021-09-16

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

Conditions

  • Acute Episode of Overt Hepatic Encephalopathy
  • Hepatic Encephalopathy

Interventions

DRUG

ornithine phenylacetate

Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation

DRUG

placebo intravenous infusion

Placebo for continuous IV infusion that is visually identical to the experimental product

Sponsors & Collaborators

  • Ocera Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Ocera Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-07
Primary Completion
2016-12-29
Completion
2016-12-29

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Russia
  • Spain

Study Locations

More Related Trials

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 NCT01966419 on ClinicalTrials.gov