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

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)

ClinicalTrials.gov ID

NCT01966419

Acronym / sponsor ID

STOP-HE / OCR002-HE209

Conditions

Acute Episode of Overt Hepatic Encephalopathy, Hepatic Encephalopathy

Keywords

hepatic encephalopathy, hyperammonemia, cirrhosis, ornithine phenylacetate, OCR-002

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

231 participants (actual)

Lead sponsor

Ocera Therapeutics, Inc.Industry (pharma, biotech, devices)

Study start

7 Jan 2014 (actual)

Primary completion

29 Dec 2016 (actual)

Study completion

29 Dec 2016 (actual)

First posted

21 Oct 2013 (estimated)

Results

Posted 16 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (participant, investigator)

Number of arms

2

Who may qualify

Ages

18 to 75 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Percentage of Participants in Each HE Stage

   Time frame: Baseline to End of Study (through 3 hours post end-of-infusion)

   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)

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 35238476Safadi R, Rahimi RS, Thabut D, Bajaj JS, Ram Bhamidimarri K, Pyrsopoulos N, Potthoff A, Bukofzer S, Wang L, Jamil K, Devarakonda KR. Pharmacokinetics/pharmacodynamics of L-ornithine phenylacetate in overt hepatic encephalopathy and the effect of plasma ammonia concentration reduction on clinical outcomes. Clin Transl Sci. 2022 Jun;15(6):1449-1459. doi: 10.1111/cts.13257. Epub 2022 Mar 3.
• Derived from this study: PubMed 34786649Wang X, Vilchez RA. Population Pharmacokinetic Analysis to Assist Dose Selection of the L-Ornithine Salt of Phenylacetic Acid. Clin Pharmacokinet. 2022 Apr;61(4):515-526. doi: 10.1007/s40262-021-01075-1. Epub 2021 Nov 17.
• Derived from this study: PubMed 33069881Rahimi RS, Safadi R, Thabut D, Bhamidimarri KR, Pyrsopoulos N, Potthoff A, Bukofzer S, Bajaj JS. Efficacy and Safety of Ornithine Phenylacetate for Treating Overt Hepatic Encephalopathy in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2626-2635.e7. doi: 10.1016/j.cgh.2020.10.019. Epub 2020 Oct 16.
• Individual participant dataSharing planned: No. Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT01966419) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

131 sites in 17 countries: see every site and its status.