CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Nitisinonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01734889
NCT01734889Phase 1Completed
CompareCT.gov

Taste and Palatability of Orfadin Suspension. An Open, Non-controlled 3 Day Study in Pediatric Patients With Hereditary Tyrosinemia Type 1 Treated With Orfadin.

Swedish Orphan Biovitrum·interventional·Posted Nov 28, 2012·Updated Nov 6, 2014

In Brief

A Phase 1 clinical trial evaluating Nitisinone for Hereditary Tyrosinemia, Type I. Completed, enrolled 18 participants across 7 sites in 3 countries.

Detailed Summary

The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Tyrosinemia, Type I
CountriesFrance, Germany, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 28, 2012
Enrollment StartOct 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.6 years ago

Interventions

Nitisinonedrug

Oral suspension