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Tyrosinemias clinical trials

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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NCT ID: NCT03284658 Withdrawn - Metabolic Disorders Clinical Trials

Biomarker for the Early Diagnosis and Monitoring in Tyrosinemia Type 1 (BioTyrosin)

BioTyrosin
Start date: August 20, 2018
Phase:
Study type: Observational

Development of a new MS-based biomarker for the early and sensitive diagnosis of Tyrosinemia type 1 from blood (plasma)

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.

NCT ID: NCT00004443 Completed - Tyrosinemia I Clinical Trials

Study of NTBC for Tyrosinemia I

Start date: October 1998
Phase: N/A
Study type: Interventional

OBJECTIVES: I. Assess the safety and efficacy of NTBC in children with tyrosinemia I. II. Evaluate the effects of NTBC on survival, rate of neurologic crises, improvement in renal tubular damage, reduction in the need for liver transplantation, and reduction in the development of hepatocarcinoma in these patients.

NCT ID: NCT00004333 Completed - Tyrosinemia, Type I Clinical Trials

Phase II Study of the Enzyme Inhibitor NTBC for Tyrosinemia Type I

Start date: November 1994
Phase: Phase 2
Study type: Interventional

OBJECTIVES: Assess whether 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (NTBC) at 0.6 mg/kg per day prevents liver failure in at least 1 patient with tyrosinemia type I.