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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

October 11, 2013
July 8, 2014
November 2013
July 2015   (final data collection date for primary outcome measure)
Change from Baseline in Hepatic Encephalopathy Stage [ Time Frame: Up to Study Day 19 ] [ Designated as safety issue: Yes ]
Same as current
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 ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: Up to Study Day 19 ] [ Designated as safety issue: No ]
Same as current
Change from Baseline in Glasgow Coma Scale [ Time Frame: Up to Study Day 19 ] [ Designated as safety issue: Yes ]
Same as current
 
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
  • Experimental: 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.
 
Recruiting
140
Not Provided
July 2015   (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
Both
18 Years to 75 Years
No
Contact: Connie Cosentino, R.N. 919-328-1131 ccosentino@ocerainc.com
Contact: Jennifer Atwell 919-328-1122 jatwell@ocerainc.com
United States,   Canada
 
NCT01966419
OCR002-HE209
Yes
Ocera Therapeutics
Ocera Therapeutics
Not Provided
Study Chair: Franck Rousseau, M.D. Ocera Therapeutics, Inc.
Ocera Therapeutics
July 2014

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