Ornithine

Generic Name: Ornithine

Brand Names: Primene

Drug Type: Small Molecule

Chemical Formula: C_₅H_₁₂N_₂O_₂

CAS Number: 70-26-8

Unique Ingredient Identifier: E524N2IXA3

Background: Produced during the urea cycle, ornithine is an amino acid produced from the splitting off of urea from arginine. L-Ornithine allows for the disposal of excess nitrogen and acts as a precursor of citrulline and arginine.

Indication: Used for nutritional supplementation, also for treating dietary shortage or imbalance. It has been claimed that ornithine improves athletic performance, has anabolic effects, has wound-healing effects, and is immuno-enhancing.

Associated Conditions: Hepatic Encephalopathy (HE)

Associated Therapies: Amino acid supplementation

Clinical Trials

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

Not Applicable

Not yet recruiting

Conditions: Overt Hepatic Encephalopathy

Interventions: Drug: Human albumin infusion at a modified dosage
Drug: Human albumin infusion at a routine dosage
Drug: Lactulose
Drug: Rifaximin
Drug: Ornithine Aspartate
Drug: Branched-Chain Amino Acids
Drug: Arginine

First Posted Date: 2024-07-03

Last Posted Date: 2025-03-04

Lead Sponsor: General Hospital of Shenyang Military Region

Target Recruit Count: 174

Registration Number: NCT06483737

Locations: 🇨🇳
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area), Shenyang, Liaoning, China

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

Phase 4

Not yet recruiting

Conditions: Hepatic Encephalopathy Stage 2
Hepatic Encephalopathy Stage 3
Hepatic Encephalopathy Stage 4

Interventions: Drug: Lactulose oral solution
Drug: Polyethylene Glycols
Drug: L-ornithine L-aspartate

First Posted Date: 2023-06-27

Last Posted Date: 2023-07-13

Lead Sponsor: Jinnah Postgraduate Medical Centre

Target Recruit Count: 360

Registration Number: NCT05920213

Locations: 🇵🇰
Nishtar Medical Univeristy and Hospital, Multan, Punjab, Pakistan
🇵🇰
Medical ICU, Jinnah Postgraduate Medical Centre, Karachi, Sindh, Pakistan
🇵🇰
Sheikh Zayed Medical College/Hospital, Rahim Yar Khan, Punjab, Pakistan

and more 3 locations

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.

Not Applicable

Not yet recruiting

Conditions: Liver Failure, Acute

Interventions: Drug: L-ornithine L-Aspartate
Drug: Placebo

First Posted Date: 2023-03-21

Last Posted Date: 2023-03-21

Lead Sponsor: Institute of Liver and Biliary Sciences, India

Target Recruit Count: 32

Registration Number: NCT05778461

Locations: 🇮🇳
Institute of Liver and Biliary Sciences, New Delhi, India

Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome

Phase 4

Active, not recruiting

Conditions: Cirrhosis

Interventions: Drug: L-ornithine L-aspartate

First Posted Date: 2023-02-21

Last Posted Date: 2025-02-10

Lead Sponsor: Medical University of Graz

Target Recruit Count: 55

Registration Number: NCT05737030

Locations: 🇦🇹
Department of Internal Medicine, Medical University of Graz, Graz, Austria

The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules

Phase 4

Conditions: Non-alcoholic Fatty Liver Disease

Interventions: Drug: Ornithine aspartate granule
Drug: Silymarin capsule
Drug: Silymarin capsule simulant
Drug: Ornithine aspartate granule simulant

First Posted Date: 2021-09-13

Last Posted Date: 2021-09-21

Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 240

Registration Number: NCT05042245

Locations: 🇨🇳
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

Phase 4

Completed

Conditions: Hepatic Encephalopathy

Interventions: Drug: Lactulose
Drug: L-ornithine L-aspartate
Drug: Rifaximin
Drug: Placebo

First Posted Date: 2014-06-06

Last Posted Date: 2018-05-22

Lead Sponsor: Hospital General de Mexico

Target Recruit Count: 88

Registration Number: NCT02158182

Locations: 🇲🇽
Hospital General de Mexico, Mexico City, Mexico

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

Phase 2

Completed

Conditions: Hepatic Encephalopathy
Acute Episode of Overt Hepatic Encephalopathy

Interventions: Drug: ornithine phenylacetate
Drug: placebo intravenous infusion

First Posted Date: 2013-10-21

Last Posted Date: 2021-09-16

Lead Sponsor: Ocera Therapeutics, Inc.

Target Recruit Count: 231

Registration Number: NCT01966419

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Phase 4

Completed

Conditions: Cirrhosis of Liver
Hepatic Encephalopathy

Interventions: Drug: L-ornithine L-aspartate
Drug: Placebo

First Posted Date: 2012-11-07

Last Posted Date: 2017-02-08

Lead Sponsor: Dayanand Medical College and Hospital

Target Recruit Count: 200

Registration Number: NCT01722578

Locations: 🇮🇳
Department of Gastroenterology, D.M.C. and Hospital, Ludhiana, Punjab, India
🇮🇳
G.B. Pant Hospital, New Delhi, India

Emergency Use of OCR-002 in Acute Liver Failure (ALF)

Conditions: Acute Liver Failure

First Posted Date: 2012-07-06

Last Posted Date: 2021-06-24

Lead Sponsor: Ocera Therapeutics, Inc.

Registration Number: NCT01634230

Locations: 🇺🇸
University of Arkansas, Little Rock, Arkansas, United States

Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury

Phase 2

Completed

Conditions: Acute Liver Failure
Acute Liver Injury

Interventions: Drug: Ornithine Phenylacetate

First Posted Date: 2012-03-08

Last Posted Date: 2018-10-30

Lead Sponsor: William Lee

Target Recruit Count: 47

Registration Number: NCT01548690

Locations: 🇺🇸
The Ohio State University, Columbus, Ohio, United States
🇺🇸
University of Washington, Seattle, Washington, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 8 locations

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