An AllTrials project

NCT03933410: An overdue trial by Kaleido Biosciences

This trial is overdue. It was due to report 1 year, 10 months ago.

Think we've made a mistake? Before contacting us, review the criteria in our paper. In particular, bear in mind the following:

  • We can only rely on the structured data that sponsors put into the registry: they may enter incorrect or incomplete data.
  • Reporting in a journal is not enough. The FDAAA rules state that the trial must be reported on ClinicalTrials.gov.
  • Terminated trials are required to report results. Only withdrawn trials (which never recruited a single patient) are not.

Full data

Full entry on ClinicalTrials.gov NCT03933410
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
Results Status Overdue
ACT or pACT? This is what FDAAA officially calls an "Applicable Clinical Trial"
Start date Sept. 17, 2019
Completion date Feb. 2, 2021
Required reporting date Feb. 2, 2024, midnight
Actual reporting date None
Date last checked at ClinicalTrials.gov Dec. 12, 2025
Days late 679