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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ocera Therapeutics
Sponsor:
Information provided by (Responsible Party):
Ocera Therapeutics
ClinicalTrials.gov Identifier:
NCT01966419
First received: October 11, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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: 140
Study Start Date: November 2013
Estimated Primary Completion Date: July 2015 (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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01966419

Contacts
Contact: Connie Cosentino, R.N. 919-328-1131 ccosentino@ocerainc.com
Contact: Jennifer Atwell 919-328-1122 jatwell@ocerainc.com

  Show 45 Study Locations
Sponsors and Collaborators
Ocera Therapeutics
Investigators
Study Chair: Franck Rousseau, M.D. Ocera Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Ocera Therapeutics
ClinicalTrials.gov Identifier: NCT01966419     History of Changes
Other Study ID Numbers: OCR002-HE209
Study First Received: October 11, 2013
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ocera Therapeutics:
hepatic encephalopathy
hyperammonemia
cirrhosis
ornithine phenylacetate
OCR-002

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Phenylacetic acid
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014