Amgen: Urea Cycle Disorders, Inborn trials

The registry lists 10 Urea Cycle Disorders, Inborn studies with Amgen as lead sponsor. 0 are open to participants now and 9 have results posted.

Phase 1 1Phase 2 2Phase 3 3Phase 4 3No phase 1(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)CompletedNCT03335488Phase 4Results posted
• A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle DisordersCompletedNCT02246218Phase 4Results posted
• Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)TerminatedNCT01948427Results posted
• Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)CompletedNCT01347073Phase 3Results posted
• To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)CompletedNCT01257737Phase 4Results posted
• Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle DisordersCompletedNCT00992459Phase 3Results posted
• Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle DisordersCompletedNCT00947544Phase 2Results posted
• Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)CompletedNCT00947297Phase 3Results posted
• Dose-Escalation Safety Study of HPN-100 to Treat Urea Cycle DisordersCompletedNCT00551200Phase 2Results posted
• 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 GroupCompletedNCT00986895Phase 1