Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial

Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.

Start Date01 May 2025

Sponsor / Collaborator

The General Hospital of Shenyang Military Region

NCT05920213

/ Not yet recruitingPhase 4IIT

HELP Trial: Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy

The goal of this clinical trial is to compare the efficacy of L-ornithine L-aspartate and Polyethylene Glycol in Cirrhotic Patients with Overt Hepatic Encephalopathy.
Participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to the patient's health. Treatments that they will receive after inclusion in the study, will be the standard treatment (Lactulose) along with additional medication as part of our research (LOLA or Polyethylene glycol).

Start Date01 Oct 2023

Sponsor / Collaborator

Jinnah Post Graduate Medical Centre

NCT05778461

/ Not yet recruitingNot ApplicableIIT

Efficacy of L-ornithine L-aspartate and Therapeutic Plasma Exchange Versus Plasma Exchange Alone in Lowering Ammonia and Improving Outcomes in Pediatric Acute Liver Failure: A Randomized Controlled Trial

Pediatric acute liver failure (PALF) is associated with very high mortality and morbidity with native liver survival varying between 21 to 75%.Hyperammonemia manifesting as hepatic encephalopathy and causing cerebral edema isresponsible for poor neurological outcome in ALF. Ammonia lowering measures have led to improvement in HE and higher native liver survival. L-ornithine L-aspartate (LOLA), a salt of natural amino-acids ornithine and aspartate, is an importantammonia scavenging drug. It acts as a substrate for urea cycle in liver and also converts ammonia to glutamine in perivenous hepatocytes as well as in the muscles.This drug has been shown to reduce ammonia and improve hepatic encephalopathy in cirrhoticadults.However, the issue with this drug is that the glutamine formed can reconvert to ammonia by the action of glutaminase, possibly, the reason why it failed to show decrease in ammonia and improvement in native liver survival in a randomized controlled trial in adult ALF. In western countries, ornithine phenylacetate has been used where ornithine converts ammonia to glutamine and phenylacetate then binds to this glutamine to form phenylacetylgutamine and eliminates it. Therapeutic plasma exchange (TPE), both high volume and standard volume has been shown to improve native liver survival in adults with ALF and is the standard of care in management of ALF and a grade 1 recommendation by all eminent liver societies.TPE leads to decreased ammonia. Although rate of ammonia formation is multiple times higher than rate of ammonia removal by plasmapheresis, this ammonia reduction is an indirect effect of glutamine removal by TPE. Glutamine, thus, acts as a reservoir for clearance of ammonia (in muscles and perivenous hepatocytes).In contrast to adults, the response to therapeutic plasma exchange has not been as encouraging inchildren, yet, most centers continue to use it based on recommendations in adults. Based on the knowledge that LOLA converts ammonia to glutamine and TPE clears glutamine from plasma, the investigators hypothesize that LOLA would act in synergestic way with TPE to lower ammonia levels, resulting in improvement in HE and better native liver survival in pediatric ALF. The goal of this clinical trial is to compare L-ornithine L-aspartate and therapeutic plasma exchange versus plasma exchange alone in lowering ammonia and improving outcomes in patients with pediatric acute liver failure.

Start Date15 Mar 2023

Sponsor / Collaborator

Institute of Liver & Biliary Sciences

100 Clinical Results associated with Ornithine aspartate

100 Translational Medicine associated with Ornithine aspartate

100 Patents (Medical) associated with Ornithine aspartate

359

Literatures (Medical) associated with Ornithine aspartate

27 Jan 2025·Irish medical journal

Unusual Presentation of Confusion: Hyperammonaemic Hepatic Encephalopathy Due to Intrahepatic Portosystemic Venous Shunt.

Article

Author: McCluskey, P ; Ntlholang, O ; Yousif, M ; Magee, C

PresentationA 75-year-old man presented to the emergency department with a 5-week history of confusion, daytime somnolence, and fatigue. His physical examination was unremarkable.DiagnosisInvestigations initially showed deranged Liver function tests. Extensive investigations were done following that including CT brain, MRI brain, septic screen, Arterial blood gas, and Lumbar puncture, which were all inconclusive. An Electroencephalogram was suggestive of Encephalopathy. His Ammonia level was high (123). Triphasic CT liver, revealed Intrahepatic portosystemic venous shunt and was diagnosed with hyperammonaemic hepatic encephalopathy due to Intrahepatic portosystemic venous shunt.TreatmentManagement included the commencement of Lactulose, Rifaximin, and L-ornithine L-aspartate (LOLA). An IR-guided embolisation of the porto-venous shunt was performed. At two-month review, the patient reported no further episodes of confusion.DiscussionIntrahepatic portosystemic venous shunts should be considered in the differential diagnosis of patients presenting with confusion or other unexplained neurological symptoms, especially in the presence of liver dysfunction. Early diagnosis and appropriate management are crucial for favourable outcomes.

01 Dec 2024·Journal of Pharmaceutical and Biomedical Analysis

Identification by HSQC and quantification by qHNMR innovate pharmaceutical amino acid analysis

Article

Author: Rebollar-Ramos, Daniela ; Kleps, Robert A ; Ray, G Joseph ; Lankin, David C ; Lehtivarjo, Juuso ; Niemitz, Matthias ; Pauli, Guido F ; Chen, Shao-Nong ; Korhonen, Samuli-Petrus

This study introduces a new NMR-based methodology for identification (ID) and quantification (purity, strength) assays of widely used amino acids. A detailed analysis of four amino acids and their available salts was performed with both a high-field (600 MHz) and a benchtop (60 MHz) NMR instrument. To assess sensitivity constraints, samples for ¹H NMR analysis were initially prepared using only 10 mg of analyte and 1 mg of maleic acid (MA) as an internal calibrant (IC) and secondary chemical shift reference. The characteristic dispersion of the peak patterns indicating the presence or absence of a counterion (mostly chloride) was conserved at both high and low-field strength instruments, showing that the underlying NMR spectroscopic parameters, i.e., chemical shifts and coupling constants, are independent of the magnetic field strength. However, as the verbal descriptions of ¹H NMR spectra are challenging in the context of reference materials and pharmaceutical monographs, an alternative method for the identification (ID) of amino acids is proposed that uses ¹³C NMR patterns from multiplicity-edited HSQC (ed-HSQC), which are both compound-specific and straightforward to document. For ed-HSQC measurements, the sample amount was increased to 30 mg of the analyte and several acquisition parameters were tested, including t₁ increments used in the pulse program, number of scans, and repetition time. Excellent congruence with deviations <0.1 ppm was achieved for the ¹³C chemical shifts from 1D ¹³C NMR spectra (150 MHz) vs. those extracted from ed-HSQC (15 MHz traces). Finally, all samples of amino acid candidate reference materials were quantified by ¹H qNMR (abs-qHNMR) at both 600 and 60 MHz. At high field, both IC and relative quantitations were performed, however, with the low-field instrument, only the IC method was used. The results showed that the analyzed reference material candidates were generally highly pure compounds. To achieve adequately low levels of uncertainty for such high-purity materials, the sample amounts were increased to 100 mg of analytes and 10 mg of the IC and replicates were analyzed for selected amino acids.

01 Dec 2024·Expert Opinion on Investigational Drugs

Hepatic encephalopathy: experimental drugs in development and therapeutic potential

Review

Author: Romero-Gómez, Manuel ; Muñoz-Hernández, Rocío ; Gil-Gómez, Antonio ; Martínez, Filomeno ; Jiménez, Fernando

INTRODUCTIONHepatic encephalopathy (HE) presents a complex pathophysiology, creating multiple potential treatment avenues. This review covers current and emerging treatments for HE.AREAS COVEREDStandard therapies, including non-absorbable disaccharides and rifaximin, are widely used but show inconsistent efficacy. Alternatives such as polyethylene glycol and L-ornithine L-aspartate have been effective in certain cases. Advancements in understanding HE reveal a growing need for personalized treatments. Novel approaches targeting immune modulation and neuroinflammation are under investigation, though clinical translation is slow. Nutritional interventions and fecal microbiota transplantation show potential but lack robust evidence. Innovative therapies like gene and cell therapies, as well as extracellular vesicles from mesenchymal stem cells, present promising avenues for liver disease treatment, potentially benefiting HE.EXPERT OPINIONA key challenge in HE research is the design of randomized clinical trials, which often suffer from small sample sizes, heterogeneity in patient population, and inconsistent blinding. Additionally, the multifactorial nature of HE, together with a high spontaneous response rate, complicates efforts to isolate treatment effects. Despite current limitations, ongoing research and technological advances hold promise for more effective and individualized HE treatments in the future.

News (Medical) associated with Ornithine aspartate

08 Mar 2021

·www.biospace.com

Winhealth Pharma and Merz Collaborate on Hepa-Merz® to benefit patients with liver disease in China

HANG ZHOU, China, March 8, 2021 /PRNewswire/ -- On Feb. 26th, 2021, Hongkong Winhealth Pharma Group Co., Ltd (hereinafter referred to as "Winhealth Pharma") signed a strategic cooperation agreement with Merz Pharmaceuticals GmbH (hereinafter referred to as "Merz"). The strategic cooperation between the two parties marks the obtainment of Winhealth Pharma for the exclusive commercial rights of Hepa-Merz® (L-ornithine L-aspartate, an important product under Merz' product portfolio) in China. About L-ornithine L-aspartate and hepatic encephalopathy (HE) L-ornithine L-aspartate (LOLA) is a stable salt of two amino acids that stimulates ammonia detoxification by increasing urea synthesis in the liver and muscle, thereby reducing the blood ammonia content in the brain which causes hepatic encephalopathy in cirrhotic patients. Hepa-Merz® Infusion concentrate (HMI) from Merz is the only imported LOLA in the Chinese market. Hepatic encephalopathy (HE) is a specific neurological symptom of liver cirrhosis and a common cause for hospitalization of patients. Hepatic encephalopathy has an impact on patient's quality of life and marks the poor prognosis indicator for patients with liver cirrhosis. According to domestic data, the incidence of mild hepatic encephalopathy (MHE) in liver cirrhosis is 38.8-85.0%. L-ornithine L-aspartate (Hepa-Merz®) infusion particularly proved to be effective in preventing the development of hepatic encephalopathy in those cirrhotic patients with acute emergency complications (e.g. variceal bleeding). Hepa-Merz® contributes therefore to the improvement of economic and social burden in cirrhotic patients. Stefan Brinkmann, Managing Director of Merz Therapeutics, emphasized: "At Merz Therapeutics, it is our mission to bring better outcomes to more patients. We are very pleased and proud about the new contract between Winhealth Pharma and Merz, as it will allow patients with liver disease in China to receive an effective and beneficial treatment to ease their burden." Mr. Jack Wang, Chairman and CEO of Winhealth Pharma, pointed out: "It is exciting to reach cooperation with Merz again. This is another brand-new milestone since the first cooperation on Contractubex® in 2017, which will accelerate the promotion of the product portfolio layout of hepatobiliary digestive line in the mature pharmaceutical business of Winhealth Pharma. Meanwhile, based on the established strategic partnership, the two parties will further deepen cooperation and integrate the advantages of both sides, so that Hepa-Merz® can better benefit domestic patients with hepatic encephalopathy and meet the needs of more unmet patients." About Merz Merz Therapeutics, a business of Merz Pharmaceuticals GmbH, is headquartered in Frankfurt, Germany and is represented in more than 90 countries. Merz Pharmaceuticals GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated more than 110 years to developing innovations that serve unmet patient and customer needs. About Winhealth Pharma Winhealth Pharma is a commercial-stage biopharmaceutical company aiming at fulfilling severely unmet or underserved medical needs for patients with rare diseases and other critical medical conditions in China and surrounding regions. Since its inception, Winhealth has been committed to sourcing, developing, and commercializing innovative therapies from leading biotech and pharmaceutical companies worldwide.

Collaborate

100 Deals associated with Ornithine aspartate

External Link

KEGG	Wiki	ATC	Drug Bank
D08303	Ornithine aspartate	A05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperammonemia	China	Merz Pharma GmbH & Co. KGaA	04 Aug 2000
Hepatic Encephalopathy	Germany	Merz Pharma GmbH & Co. KGaA	01 Jan 1969

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatic Encephalopathy	Preclinical	North America	-	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2015	Not Applicable	Hepatic Encephalopathy	126	Lactulose	rzgxsfbbum(ctoixcvndx) = qyejabhqni nrhyapyzta (jzrozwmtke ) View more	Negative	01 Oct 2015
				Rifaximin	rzgxsfbbum(ctoixcvndx) = lhhvlobnld nrhyapyzta (jzrozwmtke ) View more
ASCO2013	Not Applicable	Mycoses	413	Hepa systems (HEPA filters)	nydwzelmat(lntjjvsmig) = eihcvhzrwn tyurukutzz (rantgnlbsm )	-	20 May 2013
NCT00470314 (Pubmed \| Gastroenterology)	Phase 2	Liver Failure, Acute	201	Placebo	(ayxfpsydah) = sowrbshxow qobdoucsdk (epsqzrjpsh )	Negative	01 Jun 2009
				L-ornithine L-aspartate (LOLA)	(ayxfpsydah) = wnrymtwftr qobdoucsdk (epsqzrjpsh )

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