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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Ocera Therapeutics
Information provided by (Responsible Party):
Ocera Therapeutics Identifier:
First received: October 11, 2013
Last updated: May 19, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Acute Episode of Overt Hepatic Encephalopathy
Hepatic Encephalopathy
Drug: ornithine phenylacetate
Drug: placebo intravenous infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized Phase 2B Study Evaluating Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Cirrhotic Patients With Associated Hyperammonemia and an Episode of Hepatic Encephalopathy STOP-HE Study

Resource links provided by NLM:

Further study details as provided by Ocera Therapeutics:

Primary Outcome Measures:
  • Change from Baseline in Hepatic Encephalopathy Stage [ Time Frame: Up to Study Day 19 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline in Modified Orientation Log [ Time Frame: Up to Study Day 19 ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: Up to Study Day 19 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from Baseline in Glasgow Coma Scale [ Time Frame: Up to Study Day 19 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: November 2013
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ornithine phenylacetate
continuous intravenous infusion of ornithine phenylacetate for up to 5 days on top of standard of care
Drug: ornithine phenylacetate
dose levels predicated on level of hepatic decompensation
Other Name: OCR-002
Placebo Comparator: placebo intravenous infusion
continuous intravenous infusion of placebo up to 5 days on top of standard of care
Drug: placebo intravenous infusion
visually identical to active experimental
Other Name: 5% dextrose in water

Detailed Description:
This is a multicenter, randomized, double-blind, placebo-controlled study of ornithine phenylacetate (OCR-002) administered intravenously to hospitalized patients with cirrhosis, hyperammonemia, and an acute episode of hepatic encephalopathy administered on top of standard of care treatment.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01966419

Contact: Connie Cosentino, R.N. 919-328-1131
Contact: Jennifer Atwell 919-328-1122

  Show 100 Study Locations
Sponsors and Collaborators
Ocera Therapeutics
Study Chair: Stan Bukofzer, M.D. Ocera Therapeutics, Inc.
  More Information

Responsible Party: Ocera Therapeutics Identifier: NCT01966419     History of Changes
Other Study ID Numbers: OCR002-HE209 
Study First Received: October 11, 2013
Last Updated: May 19, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Ocera Therapeutics:
hepatic encephalopathy
ornithine phenylacetate

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Liver Failure
Metabolic Diseases
Nervous System Diseases
Phenylacetic acid
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2016