NCT02246218 is a Phase 4 clinical trial of RAVICTI in Urea Cycle Disorder, sponsored by Amgen.

Who is sponsoring NCT02246218?

NCT02246218 is sponsored by Amgen.

What drugs are being tested in NCT02246218?

Interventions in NCT02246218: RAVICTI.

What condition does NCT02246218 study?

NCT02246218 studies Urea Cycle Disorder.

Is NCT02246218 still recruiting?

NCT02246218 is currently completed. Last updated 1 July 2024.

Are results published for NCT02246218?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-01 · How we verify

NCT02246218

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders

Completed Phase 4 Results posted Last updated 1 July 2024

What this trial tests

Phase 4 trial testing RAVICTI in Urea Cycle Disorder in 27 participants. Completed in 17 July 2017.

Timeline

31 December 2014

Primary endpoint
17 October 2016

17 July 2017

Quick facts

Lead sponsor	Amgen
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	31 December 2014
Primary completion	17 October 2016
Estimated completion	17 July 2017
Sites	17 locations across Canada, United States

Drugs / interventions tested

RAVICTI (GLYCEROL PHENYLBUTYRATE) — full drug profile →

Conditions studied

Urea Cycle Disorder — all drugs for Urea Cycle Disorder →

Sponsor

Amgen — full company profile →

Who can join

Adults 1 Day to 2, any sex, with Urea Cycle Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Successful Transition to RAVICTI With Controlled Ammonia (i.e. No Clinical Symptoms and Ammonia < 100 μmol/L): Cohort of 2 Months to <2 Years Participants Primary · Up to Day 4

The percentage of participants with successful transition is based on Investigator response to the question, "Has transition to 100% RAVICTI been successful with controlled ammonia?" For participants 2 months of age and older, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	100

Percentage of Participants With Successful Transition to RAVICTI With Controlled Ammonia (i.e. No Clinical Symptoms and Ammonia < 100 μmol/L): Cohort of 0 Months to <2 Months Participants Primary · Up to Day 4

The percentage of participants with successful transition is based on Investigator response to the question, "Has transition to 100% RAVICTI been successful with controlled ammonia?" For participants \< 2 months of age, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to sta

Group	Value	95% CI
RAVICTI: Age 0 to < 2 Months	100

Rate of Hyperammonemic Crises (HACs): Cohort of 2 Months to <2 Years Participants Secondary · Day 8 through up to Month 6

HAC is defined having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension is calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group.

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.005

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Deaths, and Discontinuations Due to TEAEs: Cohort of 2 Months to <2 Years Participants Secondary · From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 9.13 [6.838] months).

An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related,

≥ 1 TEAE

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	10

≥ 1 Related TEAE

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	4

≥ 1 Serious TEAE

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	6

≥ 1 Serious Related TEAE

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0

Fatal Outcome TEAE

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	1

≥ 1 TEAE Leading to Study Discontinuation

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	1

Amino Acid Assessment: Baseline and Change From Baseline in Glutamate Up to Month 24: Cohort of 2 Months to <2 Years Participants Secondary · Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	122.43	± 118.620

Day 7 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-54.50	± 92.626

Month 2 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	7.80	± 25.646

Month 3 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-16.33	± 39.209

Month 4 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-13.00	± 39.590

Month 5 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.25	± 13.426

Month 6 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-2.20	± 34.463

Month 9 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	30.80	± 17.092

Amino Acid Assessment: Baseline and Change From Baseline in Glutamine Up to Month 24: Cohort of 2 Months to <2 Years Participants Secondary · Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	750.43	± 309.000

Day 7 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-184.33	± 168.657

Month 2 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-174.60	± 318.249

Month 3 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-374.00	± 425.903

Month 4 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-252.75	± 323.852

Month 5 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-370.25	± 377.222

Month 6 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-113.20	± 519.710

Month 9 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-446.53	± 360.457

Amino Acid Assessment: Baseline and Change From Baseline in Sum of Glutamine and Glutamate Up to Month 24: Cohort of 2 Months to <2 Years Participants Secondary · Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	872.86	± 381.005

Day 7 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-238.83	± 203.567

Month 2 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-166.80	± 332.421

Month 3 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-390.33	± 462.292

Month 4 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-265.75	± 339.015

Month 5 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-370.00	± 379.884

Month 6 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-115.40	± 546.796

Month 9 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-415.73	± 365.419

Amino Acid Assessment: Baseline and Change From Baseline in Isoleucine Up to Month 24: Cohort of 2 Months to <2 Years Participants Secondary · Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	54.86	± 19.497

Day 7 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	2.67	± 19.159

Month 2 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	4.20	± 45.861

Month 3 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-25.67	± 16.743

Month 4 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-20.25	± 20.353

Month 5 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-20.00	± 36.341

Month 6 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-16.40	± 12.137

Month 9 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-6.73	± 13.342

Amino Acid Assessment: Baseline and Change From Baseline in Leucine Up to Month 24: Cohort of 2 Months to <2 Years Participants Secondary · Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	90.86	± 29.249

Day 7 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-0.83	± 32.762

Month 2 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	9.80	± 65.975

Month 3 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-33.00	± 25.239

Month 4 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-31.25	± 24.771

Month 5 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-39.50	± 61.136

Month 6 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-25.40	± 13.594

Month 9 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-19.13	± 39.322

Amino Acid Assessment: Baseline and Change From Baseline in Valine Up to Month 24: Cohort of 2 Months to <2 Years Participants Secondary · Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24

Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	171.43	± 42.887

Day 7 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	4.00	± 24.133

Month 2 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	40.60	± 90.057

Month 3 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-27.33	± 37.018

Month 4 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-31.50	± 29.760

Month 5 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-56.00	± 75.939

Month 6 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-21.60	± 18.202

Month 9 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-11.90	± 71.753

Assessment of Growth and Development: Baseline and Change From Baseline in Body Mass Index (BMI) Z-Score Up to Month 24: Cohort of 2 Months to <2 Years Participants Secondary · Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender.

Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.8107	± 2.17017

Month 1 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-0.2385	± 0.77830

Month 2 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-0.0249	± 0.74861

Month 3 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.1815	± 0.86056

Month 4 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.4434	± 0.94854

Month 5 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.1484	± 0.76293

Month 6 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.2497	± 0.80923

Month 9 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.6407	± 0.98695

Assessment of Growth and Development: Baseline and Change From Baseline in Body Surface Area (BSA) Z-Score Up to Month 24: Cohort of 2 Months to <2 Years Participants Secondary · Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24

To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender.

Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.7143	± 2.14922

Month 1 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-0.2105	± 0.74135

Month 2 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	-0.0704	± 0.70393

Month 3 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.1065	± 0.70165

Month 4 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.3365	± 0.77672

Month 5 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.1043	± 0.56747

Month 6 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.1842	± 0.62205

Month 9 change from Baseline

Group	Value	95% CI
RAVICTI: Age 2 Months to < 2 Years	0.4875	± 0.86137

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 9.13 [6.838] months for Cohort of 2 Months to <2 Years Participants and 10.67 [6.142] months for Cohort of 0 Months to <2 Months Participants).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RAVICTI: Age 2 Months to < 2 Years

Serious: 6/10 (60%)

Deaths: 1/10

RAVICTI: Age 0 to <2 Months

Serious: 11/16 (69%)

Deaths: 0/16

Serious adverse events (30 terms)

Reaction	System	RAVICTI: Age 2 Months to <…	RAVICTI: Age 0 to <2 Months
Hyperammonaemia	Metabolism and nutrition disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Viral infection	Infections and infestations	—	—
Ammonia increased	Investigations	—	—
Cyanosis	Cardiac disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Apnoeic attack	Respiratory, thoracic and mediastinal disorders	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	—	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—	—
Lethargy	Nervous system disorders	—	—
Pyrexia	General disorders	—	—
Pneumatosis intestinalis	Gastrointestinal disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Feeding disorder	Metabolism and nutrition disorders	—	—
Croup infectious	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Peritonitis	Infections and infestations	—	—
Rhinovirus infection	Infections and infestations	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Bacteraemia	Infections and infestations	—	—
Cellulitis	Infections and infestations	—	—
Device related infection	Infections and infestations	—	—

Other adverse events (97 terms — click to expand)

Reaction	System	RAVICTI: Age 2 Months to <…	RAVICTI: Age 0 to <2 Months
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Dermatitis diaper	Skin and subcutaneous tissue disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Teething	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Ear infection	Infections and infestations	—	—
Pyrexia	General disorders	—	—
Hepatic enzyme increased	Investigations	—	—
Plagiocephaly	Congenital, familial and genetic disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Thrombocytosis	Blood and lymphatic system disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Metabolic acidosis	Metabolism and nutrition disorders	—	—
Hypophagia	Metabolism and nutrition disorders	—	—
Hyperammonaemia	Metabolism and nutrition disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Otitis media	Infections and infestations	—	—
Oral candidiasis	Infections and infestations	—	—
Venous thrombosis limb	Vascular disorders	—	—
Seasonal allergy	Immune system disorders	—	—
Catheter site rash	General disorders	—	—
Device occlusion	General disorders	—	—
Drug withdrawal syndrome	General disorders	—	—
Medical device site haemorrhage	General disorders	—	—
Agitation	Psychiatric disorders	—	—
Irritability	Psychiatric disorders	—	—
Stoma site reaction	Injury, poisoning and procedural complications	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—
Amino acid level decreased	Investigations	—	—
Ammonia increased	Investigations	—	—

Most-reported serious reactions: Hyperammonaemia, Vomiting, Viral infection, Ammonia increased, Cyanosis, Neutropenia, Apnoeic attack, Asthma.

Data from ClinicalTrials.gov NCT02246218 adverse events section.

Sponsor's own description

This is an open-label study consisting of a transition period to RAVICTI, followed by a safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI, depending on age at enrollment. It is designed to capture information important for evaluating safety, pharmacokinetics and efficacy in young children. Subjects who are followed by or referred to the Investigator for management of their UCD. Subjects eligible for this study will include patients ranging from newborn to \< 2 years of age with either a diagnosed or clinically suspected UCD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Medium-chain Acyl-COA dehydrogenase deficiency: Pathogenesis, diagnosis, and treatment.
Mason E, Hindmarch CCT, Dunham-Snary KJ. · · 2023 · cited 32× · PMID 36300606 · DOI 10.1002/edm2.385

Verify or expand the search:

Other trials of RAVICTI

Trials testing the same drug.

NCT03335488 — Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCD · Phase 4 · completed
NCT02094222 — Expanded Access Protocol for an Intermediate Size Population - RAVICTI for Byler Disease · no longer available

Other recruiting trials for Urea Cycle Disorder

Currently open trials in the same condition.

NCT04908319 — Hepatic Histopathology in Urea Cycle Disorders · recruiting
NCT04612764 — Liver Disease in Urea Cycle Disorders · recruiting

Other Amgen trials

Trials by the same sponsor.

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NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02246218 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 1 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02246218.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02246218

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (30 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of RAVICTI

Other recruiting trials for Urea Cycle Disorder

Other Amgen trials

Verify against primary sources