Study to Evaluate the Efficacy of HepaStem in Urea Cycle Disorders

See also
Status	Clinical Trial	Phase
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Completed	`NCT01002469` - Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment	N/A
Completed	`NCT00986895` - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group	Phase 1
Completed	`NCT01257737` - To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)	Phase 4
Recruiting	`NCT05671666` - Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients	N/A
Completed	`NCT02311283` - Pilot Study: Urea Cycle Disorders Practice Patterns and Outcomes Assessment	N/A
Completed	`NCT00992459` - Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders	Phase 3
Completed	`NCT00551200` - Dose-Escalation Safety Study of HPN-100 to Treat Urea Cycle Disorders	Phase 2
Completed	`NCT00947297` - Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)	Phase 3
Completed	`NCT02740153` - PCORI Urea Cycle Disorder Study
Completed	`NCT02051049` - Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001)
Completed	`NCT01765283` - Safety Study of HepaStem for the Treatment of Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN)	Phase 1/Phase 2
Completed	`NCT00947544` - Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders	Phase 2
Completed	`NCT01347073` - Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)	Phase 3
Completed	`NCT00718627` - Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders	Phase 2
Completed	`NCT03797131` - Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders	N/A
Completed	`NCT01549015` - Study in Healthy Subjects, Patients With Urea Cycle Disorders (UCD) and Carriers of UCD Mutations to Evaluate Urea Cycle Function	N/A
Terminated	`NCT01541722` - Oxidative Stress, Inflammation and Acute Decompensation in Urea Cycle Disorders	N/A
Completed	`NCT00345605` - Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder	Phase 2
Recruiting	`NCT00237315` - Longitudinal Study of Urea Cycle Disorders

NCT number	NCT02489292
Study type	Interventional
Source	Promethera Biosciences
Contact
Status	Completed
Phase	Phase 2
Start date	October 2014
Completion date	March 2017

Study to Evaluate the Efficacy of HepaStem in Urea Cycle Disorders Paediatric Patients (HEP002)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms