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CLINICAL TRIALS PROFILE FOR RAVICTI

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Clinical Trials for Ravicti

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01347073	Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	This non-randomized, open-label study was approximately one year in duration and consisted of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a 12-month long term treatment period involving monthly visits.
NCT01881984	Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 1	This is a medical research study to test a medication in adult patients with a disease called medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the 985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is currently FDA approved for the treatment of urea cycle disorders. Previous research suggests that Ravicti may also be effective in the treatment MCAD deficiency. This study will investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD deficiency caused by having at least one copy of the 985A>G mutation.
NCT01881984	Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation	Completed	University of Pittsburgh	Phase 1	This is a medical research study to test a medication in adult patients with a disease called medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the 985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is currently FDA approved for the treatment of urea cycle disorders. Previous research suggests that Ravicti may also be effective in the treatment MCAD deficiency. This study will investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD deficiency caused by having at least one copy of the 985A>G mutation.

Clinical Trial Conditions for Ravicti

Condition Name

Condition Name for Ravicti
Intervention	Trials
Urea Cycle Disorder	2
Byler Disease	2
Parkinson's Disease	1

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Condition MeSH

Condition MeSH for Ravicti
Intervention	Trials
Disease	3
Urea Cycle Disorders, Inborn	3
Cholestasis, Intrahepatic	2

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Clinical Trial Locations for Ravicti

Trials by Country

Trials by Country for Ravicti
Location	Trials
United States	27
Switzerland	1
Canada	1

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Trials by US State

Trials by US State for Ravicti
Location	Trials
Pennsylvania	3
Maine	2
District of Columbia	2
California	2
Oregon	2

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Clinical Trial Progress for Ravicti

Clinical Trial Phase

Clinical Trial Phase for Ravicti
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 1/Phase 2	1

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Clinical Trial Status

Clinical Trial Status for Ravicti
Clinical Trial Phase	Trials
Not yet recruiting	2
Completed	2
No longer available	1

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Clinical Trial Sponsors for Ravicti

Sponsor Name

Sponsor Name for Ravicti
Sponsor	Trials
University of Pittsburgh	3
Horizon Pharma Ireland, Ltd., Dublin Ireland	2
Horizon Therapeutics, LLC	2

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Sponsor Type

Sponsor Type for Ravicti
Sponsor	Trials
Other	7
Industry	4

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