Clinical trials: Ammonia Metabolism
Urea Cycle Disorder
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)
This is a randomized, controlled, open-label parallel arm study to assess the safety, tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to Sodium phenylbutyrate (NaPBA) in urea cycle disorder subjects…
- Trial name
- NCT03335488
- Testing
- RAVICTI, NaPBA
- Where
- 11 sites in United States, Italy and 2 more
- Volunteers
- 16 people
- Sponsor
- Amgen
Ammonia Metabolism
L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients
L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in corresponding tissues of eight normally…
- Trial name
- NCT03021876
- Testing
- L-carnitine, usual intake
- Where
- Japan
- Volunteers
- 80 people
- Sponsor
- Kochi University
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency
Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia.
- Conditions
- Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease, Ornithine Carbamoyltransferase Deficiency (Disorder), Urea Cycle Disorders, Inborn
- Trial name
- NCT06255782
- Testing
- ECUR-506
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 20 people
- Sponsor
- iECURE, Inc.
Cirrhosis, Hepatic Encephalopathy
Effect of Brief Dietary Intervention on Ammonia Levels
Study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. Patients will be given specific meals and venous ammonia analyzed over time after those meals.
- Trial name
- NCT05376488
- Testing
- One meal
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
Urea Cycle Disorders, Inborn, Urea Cycle Disorders
Phase 1/2 Study of KRRO-121 in Healthy Volunteers and Patients With UCD
Phase 1/2 Study of KRRO-121 is a randomized, placebo-controlled study in Healthy Volunteers (Phase 1 SAD and MAD) and Study Participants with Urea Cycle Disorders (Phase 2).
- Conditions
- Urea Cycle Disorders, Inborn, Urea Cycle Disorders, Ornithine Transcarbamylase (OTC) Deficiency, Arginase 1 Deficiency
- Trial name
- ANCHOR (NCT07773246)
- Testing
- KRRO-121
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Korro Bio, Inc.
Urea Cycle Disorder
Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)
THRIVE is an observational study that will collect information on patients with UCDs. THRIVE will follow enrolled participants for up to 10 years.
- Trial name
- THRIVE (NCT01948427)
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- Amgen
Acute Liver Failure, Acute on Chronic Liver Failure (ACLF)
Continuous Renal Replacement Therapy Intensity in Hyperammonemia
Acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) are life-threatening conditions often associated with hyperammonemia, hepatic encephalopathy, and multi-organ dysfunction.
- Conditions
- Acute Liver Failure, Acute on Chronic Liver Failure (ACLF), Acute Kidney Injury, Ammonia Metabolism
- Trial name
- CRITICAL (NCT06987604)
- Testing
- High-dose continuous renal replacement therapy, Conventional-dose continuous renal replacement therapy
- Where
- Brazil
- Volunteers
- 152 people
- Sponsor
- Hospital de Clinicas de Porto Alegre