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

Hepatic Encephalopathy Clinical Trial

— STOP-HE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966419
• Other study ID #: OCR002-HE209
• Secondary ID: 2013-005412-10
• Status: Completed
• Phase: Phase 2
• Start date: January 7, 2014
• Est. completion date: December 29, 2016

Study information

• Verified date: August 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 29, 2016
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Episode of Overt Hepatic Encephalopathy
• Brain Diseases
• Hepatic Encephalopathy
• Hyperammonemia

Intervention

Drug:
• ornithine phenylacetate
Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
• placebo intravenous infusion
Placebo for continuous IV infusion that is visually identical to the experimental product

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ocera Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Czechia,  Denmark,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  New Zealand,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Each HE Stage	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)