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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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