UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder — UNLOCKED  

Urea Cycle Disorder Clinical Trial

Official title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects With A Urea Cycle Disorder With Inadequate Control on Standard of Care

Status Terminated

Clinical Trial Summary

UNLOCKED: A Phase 2 Trial to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care

Clinical Trial Description

We expect the trial to enroll approximately 24 Urea Cycle Disorder (UCD) patients on standard of care with elevated ammonia levels. The planned treatment duration is eight weeks, with a primary endpoint of proportion of subjects who achieve a ≥15% reduction from baseline in fasting ammonia at the end of treatment. Patients will also be followed for safety and tolerability. This clinical trial is intended to allow us to evaluate efficacy of KB195 in reducing ammonia in UCD patients. ;

Related Conditions & MeSH terms

• Disease
• Urea Cycle Disorder
• Urea Cycle Disorders, Inborn

• NCT number: NCT03933410
• Study type: Interventional
• Source: Kaleido Biosciences
• Status: Terminated
• Phase: Phase 2
• Start date: September 17, 2019
• Completion date: March 2, 2021