Completed PHASE2 INTERVENTIONAL 5-arm NCT01828463

Dose Response Study of Nitisinone in Alkaptonuria (SONIA1)

An International, Multicentre, Randomised, Open-label, No-treatment Controlled, Parallel-group, Dose-response Study to Investigate the Effect of Once Daily Nitisinone on 24-hour Urinary Homogentisic Acid Excretion in Patients With Alkaptonuria After 4 Weeks Treatment.

Sponsor: Liverpool University Hospitals NHS Foundation Trust

Conditions Alkaptonuria

Interventions Nitisinone

Updated 6 times since 2017 Last updated: Jun 10, 2014 Started: May 31, 2013 Primary completion: Oct 31, 2013 Completion: Dec 31, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01828463, this PHASE2 trial focuses on Alkaptonuria and remains completed. Sponsored by Liverpool University Hospitals NHS Foundation Trust, it has been updated 6 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Feb 2020 — Jan 2021 [monthly]

Completed PHASE2
Jun 2018 — Feb 2020 [monthly]

Completed PHASE2

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE2

First recorded

May 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Liverpool University Hospitals NHS Foundation Trust
University of Liverpool

Data source: University of Liverpool

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Liverpool, United Kingdom