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

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ClinicalTrials.gov Identifier: NCT01966419
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ocera Therapeutics

October 11, 2013
October 21, 2013
August 21, 2018
November 2013
December 2016   (Final data collection date for primary outcome measure)
Change from Baseline in Hepatic Encephalopathy Stage [ Time Frame: Up to Study Day 19 ]
HE Staging Tool to be completed by physician
Change from Baseline in Hepatic Encephalopathy Stage [ Time Frame: Up to Study Day 19 ]
Complete list of historical versions of study NCT01966419 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Modified Orientation Log [ Time Frame: Up to Study Day 19 ]
    MOL completed by physician
  • Length of hospital stay [ Time Frame: Up to Study Day 19 ]
    Dates entered by site on CRF
  • Change from Baseline in Modified Orientation Log [ Time Frame: Up to Study Day 19 ]
  • Length of hospital stay [ Time Frame: Up to Study Day 19 ]
Change from Baseline in Glasgow Coma Scale [ Time Frame: Up to Study Day 19 ]
Coma Scale by physician
Change from Baseline in Glasgow Coma Scale [ Time Frame: Up to Study Day 19 ]
 
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
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.
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)
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Episode of Overt Hepatic Encephalopathy
  • Hepatic Encephalopathy
  • Drug: ornithine phenylacetate
    dose levels predicated on level of hepatic decompensation
    Other Name: OCR-002
  • Drug: placebo intravenous infusion
    visually identical to active experimental
    Other Name: 5% dextrose in water
  • Active Comparator: ornithine phenylacetate
    continuous intravenous infusion of ornithine phenylacetate for up to 5 days on top of standard of care
    Intervention: Drug: ornithine phenylacetate
  • Placebo Comparator: placebo intravenous infusion
    continuous intravenous infusion of placebo up to 5 days on top of standard of care
    Intervention: Drug: placebo intravenous infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
231
200
January 2017
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Bulgaria,   Czechia,   Denmark,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   New Zealand,   Russian Federation,   Spain,   United States
Canada,   Czech Republic
 
NCT01966419
OCR002-HE209
Yes
Not Provided
Not Provided
Ocera Therapeutics
Ocera Therapeutics
Not Provided
Study Chair: Stan Bukofzer, M.D. Ocera Therapeutics, Inc.
Ocera Therapeutics
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP