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Last Updated: October 23, 2019

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CLINICAL TRIALS PROFILE FOR NITISINONE

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Clinical Trials for Nitisinone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00031161 Prevention of Dichloroacetate Toxicity Completed University of Florida N/A 2001-09-01 This is a study to determine the safety of dichloroacetate (DCA) with a low-tyrosine diet given with or without nitisinone (NTBC) in children with chronic lactic acidosis (CLA).
NCT00107783 Long-Term Study of Nitisinone to Treat Alkaptonuria Completed National Human Genome Research Institute (NHGRI) Phase 2 2005-01-01 This 3-year study will examine the safety and effectiveness of long-term use of nitisinone (Orfadin) for treating joint problems in patients with alkaptonuria, an inherited disease in which a compound called homogentisic acid accumulates. The excess homogentisic acid causes arthritis and limited joint movement. It can also cause heart valve damage and kidney stones. Patients between 30 and 80 years of age with alkaptonuria may be eligible for this study. Patients must have hip involvement, but at least one remaining hip joint. Candidates are recruited from among patients enrolled in protocol 00-HG-0141, "Clinical, Biochemical, and Molecular Investigations into Alkaptonuria." Participants may enter both protocols simultaneously. Participants are randomly assigned to one of two treatment groups: one group takes their regular medicines plus a 2-mg nitisinone capsule daily; the other group takes only their regular medicines. Patients taking nitisinone have blood tests to measure liver function 2 weeks and 6 weeks after starting treatment. Before starting therapy, all patients are admitted to the NIH Clinical Center for 4-5 days to undergo the following procedures: - Medical history and physical examination - 24-hour urine collection to test for sugar, protein, and other molecules - Blood tests for liver and thyroid function, blood counts, and blood chemistries - Blood and urine tests to measure tyrosine and other amino acids and homogentisic acid - Bone x-rays - Spiral CT (computed tomography) of the abdomen to detect kidney stones - Eye examination and evaluations by specialists in rehabilitation medicine and pain, plus other consults in skin, brain, lung, heart, and kidney, as needed All patients, whether or not they receive nitisinone, return to the Clinical Center for a 2-3 day follow-up admission every 4 months for a history and physical examination, blood tests, and two 24-hour urine collections. Every 12 months (12, 24 and 36 months after starting the study), patients also have repeat bone x-rays, spiral CT, kidney ultrasound, echocardiogram, and electrocardiogram. An MRI of the brain is done at the end of the study. Sixteen months after the end of the study enrollment period, the treated and non-treated groups are evaluated. If nitisinone has delayed the progression of joint disease in the treated group, the study continues and all patients receive the drug for the remainder of the study. If not, the study continues for another 20 months, at which time the study ends and the evaluation process is repeated. Patients who develop symptoms such as corneal crystals, pain, or severe liver or nervous system toxicity may be taken off the study.
NCT01390077 Nitisinone (NTBC) In Different Age Groups Of Patients With Alkaptonuria Active, not recruiting University of California, San Diego Phase 2/Phase 3 2011-01-01 Nitisinone is a potent inhibitor of the enzyme that catalyzes the formation of homogentisic acid, and should be an even more logical treatment for alkaptonuria than for tyrosinemia, for which it has been approved by the FDA.The objective of this research is to explore reported age related differences in toxicity of nitisinone and its pharmacokinetic underpinnings and to develop an optimal therapeutic requirement for a targeted population of presymptomatic patients. The additional effect of mixtures of amino acids excluding tyrosine will be explored to take advantage of protein synthesis to avoid elevations of tyrosine that would otherwise limit the optimal dosage of nitisinone. The study is designed to treat patients and find the optimal dosage of nitisinone to obtain maximal reduction in levels of homogentisic acid and maintain safe levels of tyrosine. The long term objective in the target population of pre-symptomatic patients is the prevention of the characteristic effects on joint cartilage and tendons.
NCT01682538 Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension Completed Swedish Orphan Biovitrum Phase 1 2012-08-01 The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.
NCT01734889 Taste and Palatability of Orfadin Suspension Completed Swedish Orphan Biovitrum Phase 1 2012-10-01 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.
NCT01828463 Dose Response Study of Nitisinone in Alkaptonuria Completed Royal Liverpool and Broadgreen University Hospitals NHS Trust Phase 2 2013-05-01 SONIA 1 is 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. They study will identify the optimal dose to decrease urine homogentisic acid to near normal levels.
NCT01828463 Dose Response Study of Nitisinone in Alkaptonuria Completed University of Liverpool Phase 2 2013-05-01 SONIA 1 is 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. They study will identify the optimal dose to decrease urine homogentisic acid to near normal levels.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nitisinone

Condition Name

Condition Name for Nitisinone
Intervention Trials
Hereditary Tyrosinemia, Type I 7
Alkaptonuria 4
Healthy 1
Drug Drug Interaction 1
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Condition MeSH

Condition MeSH for Nitisinone
Intervention Trials
Tyrosinemias 7
Ochronosis 4
Alkaptonuria 4
Albinism, Oculocutaneous 1
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Clinical Trial Locations for Nitisinone

Trials by Country

Trials by Country for Nitisinone
Location Trials
United States 4
United Kingdom 4
Germany 4
France 3
Netherlands 3
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Trials by US State

Trials by US State for Nitisinone
Location Trials
Maryland 2
California 1
Florida 1
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Clinical Trial Progress for Nitisinone

Clinical Trial Phase

Clinical Trial Phase for Nitisinone
Clinical Trial Phase Trials
Phase 3 2
Phase 2/Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Nitisinone
Clinical Trial Phase Trials
Completed 10
Active, not recruiting 3
Enrolling by invitation 2
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Clinical Trial Sponsors for Nitisinone

Sponsor Name

Sponsor Name for Nitisinone
Sponsor Trials
Swedish Orphan Biovitrum 6
Parexel 4
Cycle Pharmaceuticals Ltd. 3
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Sponsor Type

Sponsor Type for Nitisinone
Sponsor Trials
Industry 14
Other 5
NIH 3
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