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

August 19, 2021 updated by: Ocera Therapeutics, Inc.

Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Associated Hyperammonemia With an Episode of Hepatic Encephalopathy (STOP-HE Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objectives of the study were to evaluate the efficacy of OCR-002 for treatment of an acute hepatic encephalopathy (HE) episode in cirrhotic patients requiring hospitalization and the safety and tolerability of OCR-002 in hospitalized cirrhotic patients with an acute episode of HE.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3065
      • Parkville, Australia, 3050
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
    • South Australia
      • Adelaide, South Australia, Australia, 5000
      • Bedford Park, South Australia, Australia, 5042
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Austria
      • Graz, Austria, 8036
      • Vienna, Austria, 1090
      • Wien, Austria, 1160
  • Belgium
      • Bruxelles, Belgium, 1020
      • Bruxelles, Belgium, 1070
      • Bruxelles, Belgium, 1200
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
  • Bulgaria
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1606
  • Czechia
      • Brno, Czechia, 625 00
      • Praha, Czechia, 14021
      • Usti nad Labem, Czechia, 401 13
  • Denmark
      • Arhus, Denmark, 8000
      • Copenhagen, Denmark, 2100
      • Esbjerg, Denmark, 6700
      • Hvidovre, Denmark, 2650
      • Kobenhavn, Denmark, 2100
  • Estonia
      • Tartu, Estonia, 51014
  • France
      • Bordeaux, France, 33000
      • Grenoble, France, 38043
      • La Roche, France, 85925
      • Lille, France, 59037
      • Lyon, France, 69317
      • Nice, France, 06200
      • Paris, France, 75651
      • Pessac, France, 33604
      • Toulouse, France, 31053
      • Villejuif, France, 94800
  • Germany
      • Bonn, Germany, 53127
      • Freiburg, Germany, 79106
      • Halle, Germany, 06120
      • Hamburg, Germany, 20246
      • Heidelberg, Germany, 69120
      • Leipzig, Germany, 04103
      • Mainz, Germany, 55131
    • Niedersachesen
      • Hanover, Niedersachesen, Germany, D-30625
  • Hungary
      • Debrecen, Hungary, 4031
      • Gyula, Hungary, 5700
      • Kaposvar, Hungary, 7400
      • Pecs, Hungary, 7624
  • Israel
      • Haifa, Israel, 3109601
      • Haifa, Israel, 3436212
      • Jerusalem, Israel, 9112001
      • Petah-Tikva, Israel, 49372
      • Ramat-Gan, Israel, 49372
      • Safed, Israel, 13100
      • Tel Aviv, Israel, 64239
  • Italy
      • Bergamo, Italy, 24127
      • Bologna, Italy, 40138
      • Firenze, Italy, 50134
      • Milano, Italy, 20122
      • Palermo, Italy, 90141
      • Roma, Italy, 00161
      • Rozzano, Italy, 20089
      • San Giovanni Rotondo, Italy, 71013
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
      • Maastricht, Netherlands, 6229 HX
  • New Zealand
      • Auckland, New Zealand, 1142
  • Russian Federation
      • Moscow, Russian Federation, 119992
      • Moscow, Russian Federation, 111123
      • Moscow, Russian Federation, 129090
      • Moscow, Russian Federation, 117198
      • Samara, Russian Federation, 443011
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08041
      • Girona, Spain, 17007
      • La Coruña, Spain, 15706
      • Madrid, Spain, 28034
      • Madrid, Spain, 28007
      • Madrid, Spain, 28222
      • Malaga, Spain, 29010
      • Pontevedra, Spain, 36071
      • Santander, Spain, 39008
      • Sevilla, Spain, 41014
      • Valencia, Spain, 46026
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
      • Phoenix, Arizona, United States, 85006
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Coronado, California, United States, 92118
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90033
      • San Francisco, California, United States, 94115
      • San Francisco, California, United States, 94143
    • Connecticut
      • New Haven, Connecticut, United States, 06504
    • Florida
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Atlanta, Georgia, United States, 30309
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
      • Glenview, Illinois, United States, 60026
    • Iowa
      • Iowa City, Iowa, United States, 52242
      • Iowa City, Iowa, United States, 52246
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Baltimore, Maryland, United States, 21201
      • Bethesda, Maryland, United States, 20814
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Mississippi
      • Jackson, Mississippi, United States, 39216
    • Missouri
      • Columbia, Missouri, United States, 65212
    • New Jersey
      • Newark, New Jersey, United States, 07103
    • New York
      • Buffalo, New York, United States, 14215
      • New York, New York, United States, 10032
      • New York, New York, United States, 10029
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19141
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75203
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77030
    • Virginia
      • Richmond, Virginia, United States, 23249
    • Washington
      • Seattle, Washington, United States, 98104
      • Seattle, Washington, United States, 98195
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
  • Elevated venous ammonia

Exclusion Criteria:

  • Renal failure with serum creatinine > 3 mg/dL or need for dialysis
  • Molecular Adsorbent Recirculation System utilized
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ornithine phenylacetate
Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)
Drug: ornithine phenylacetate
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
Other Names:
  • OCR-002
Placebo Comparator: Placebo
Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC
Drug: placebo intravenous infusion
Placebo for continuous IV infusion that is visually identical to the experimental product
Other Names:
  • Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Each HE Stage
Time Frame: Baseline to End of Study (through 3 hours post end-of-infusion)

To support the primary endpoint of confirmed clinical response, the investigator rated participants on a 4-point staging scale, where higher scores are worse.

The stages are described as:

Stage 0/1 = Participant has no tremor of the hand when the wrist is extended (asterixis) and no confusion, even about where they are (disorientation) Stage 2 = Participant has tremor of the hand when the wrist is extended (asterixis) and is confused, not knowing where they are (disorientation) Stage 3 = Participant is tired, falling asleep, answers questions but is confused, and doesn't know where they are (Stupor, arousable but falls asleep, responsive to verbal stimuli, Obvious confusion, Gross disorientation) Stage 4 = Participant is unconscious (in a coma)
Baseline to End of Study (through 3 hours post end-of-infusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocera Therapeutics, Inc.

Investigators

  • Study Chair: Clinical Team Leader, Ocera Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2014

Primary Completion (Actual)

December 29, 2016

Study Completion (Actual)

December 29, 2016

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCR002-HE209
  • 2013-005412-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT01966419) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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