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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR ORFADIN

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Clinical Trials for Orfadin

Trial ID Title Status Sponsor Phase Summary
NCT00107783 Long-Term Study of Nitisinone to Treat Alkaptonuria Completed National Human Genome Research Institute (NHGRI) Phase 2 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.
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 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 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.
NCT01857362 Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules. Completed Swedish Orphan Biovitrum Phase 1 The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Orfadin

Condition Name

Condition Name for Orfadin
Intervention Trials
Hereditary Tyrosinemia, Type I 5
Alkaptonuria 2
Healthy Volunteers 1
Healthy 1
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Condition MeSH

Condition MeSH for Orfadin
Intervention Trials
Tyrosinemias 5
Ochronosis 2
Alkaptonuria 2
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Clinical Trial Locations for Orfadin

Trials by Country

Trials by Country for Orfadin
Location Trials
Germany 4
Netherlands 3
United Kingdom 3
France 3
Belgium 2
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Trials by US State

Trials by US State for Orfadin
Location Trials
Maryland 1
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Clinical Trial Progress for Orfadin

Clinical Trial Phase

Clinical Trial Phase for Orfadin
Clinical Trial Phase Trials
Phase 3 2
Phase 2 1
Phase 1 6
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Clinical Trial Status

Clinical Trial Status for Orfadin
Clinical Trial Phase Trials
Completed 7
Enrolling by invitation 2
Active, not recruiting 1
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Clinical Trial Sponsors for Orfadin

Sponsor Name

Sponsor Name for Orfadin
Sponsor Trials
Swedish Orphan Biovitrum 6
Parexel 3
Cycle Pharmaceuticals Ltd. 2
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Sponsor Type

Sponsor Type for Orfadin
Sponsor Trials
Industry 11
Other 1
NIH 1
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