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Hereditary Tyrosinemia, Type I clinical trials

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NCT ID: NCT06227429 Recruiting - Clinical trials for Hereditary Tyrosinemia, Type I

A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients

Start date: December 14, 2023
Phase:
Study type: Observational

This is a prospective, non-interventional, non-comparative, multicenter study to collect data on HT-1 patients in China treated with Nitisinone in a routine clinical setting. No tests or examinations are mandated in the study.

NCT ID: NCT04113772 Not yet recruiting - Clinical trials for Hereditary Tyrosinemia, Type I

Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine

Orfadin
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

he purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product are bioequivalent to the reference product Orfadin 10 mg

NCT ID: NCT03446586 Recruiting - Clinical trials for Hereditary Tyrosinemia, Type I

Hereditary Hepatorenal Tyrosinemia Natural History in Egypt and the Arab World (Multicenter Clinical Study)

Start date: April 5, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of the registry/repository is to understand the natural history of tyrosinemia in our region and to provide a mechanism to store data and specimens to support the conduct of future research about hereditary tyrosinemia among the Arabs.

NCT ID: NCT02750709 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin

Start date: October 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1) and Nitisinone 10 mg Tablets High Compritol (Test Product 2) are bioequivalent to the reference product Orfadin 10 mg capsules.

NCT ID: NCT02750345 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)

Start date: March 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1) and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are bioequivalent to the reference product Orfadin 10 mg hard capsules.

NCT ID: NCT02750332 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)

Start date: November 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions (food-effect).

NCT ID: NCT02323529 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1

HT-1
Start date: December 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to look at the steady-state serum concentrations of nitisinone when switching from twice daily and once daily dosing.

NCT ID: NCT02320084 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care

OPAL
Start date: September 2013
Phase:
Study type: Observational

The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

NCT ID: NCT01734889 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Taste and Palatability of Orfadin Suspension

Start date: October 2012
Phase: Phase 1
Study type: Interventional

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.