Ravicti ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
251尿素サイクル異常症2
299嚢胞性線維症1

251. 尿素サイクル異常症


臨床試験数 : 54 薬物数 : 61 - (DrugBank : 15) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 28
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03335488
(ClinicalTrials.gov)
February 20, 201818/10/2017Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle DisordersA Randomised, Controlled, Open-Label Parallel Arm Study of Safety, PK and Ammonia Control of RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid and Sodium Phenylbutyrate in Phenylbutyrate Treatment Naïve Patients With Urea Cycle DisordersUrea Cycle DisorderDrug: RAVICTI;Drug: NaPBAHorizon Therapeutics, LLCNULLCompletedN/A99 YearsAll16Phase 4United States;Italy;Spain;Switzerland;Belgium
2NCT02246218
(ClinicalTrials.gov)
December 31, 201417/9/2014A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle DisordersAn Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI®) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)Urea Cycle DisorderDrug: RAVICTIHorizon Therapeutics, LLCNULLCompletedN/A2 YearsAll27Phase 4United States;Canada

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02323100
(ClinicalTrials.gov)
December 2, 201818/12/2014Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)A Double Blind, Placebo Controlled, Dose Escalation Trial of Glycerol Phenylbutyrate Corrector Therapy for Cystic FibrosisCystic FibrosisDrug: Ravicti low dose;Drug: Ravicti high dose;Drug: PlaceboNational Jewish HealthUniversity of Alabama at Birmingham;Children's Hospital of Philadelphia;Johns Hopkins University;Horizon Pharma Ireland, Ltd., Dublin IrelandRecruiting18 YearsN/AAll36Phase 1/Phase 2United States