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

Ocera Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hepatic Encephalopathy; Acute Episode of Overt Hepatic Encephalopathy

Treatments: Drug: ornithine phenylacetate; Drug: placebo intravenous infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01966419

2013-005412-10 (EudraCT Number)

OCR002-HE209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 2 patient groups, including a placebo group

Ornithine phenylacetate

Active Comparator group

Description:

Participants receive ornithine phenylacetate for up to 5 days via continuous IV infusion in addition to standard of care (SOC)

Treatment:

Drug: ornithine phenylacetate

Placebo

Placebo Comparator group

Description:

Participants receive matching placebo up to 5 days via continuous IV infusion in addition to SOC

Treatment:

Drug: placebo intravenous infusion