Clinical trials: sponsored by Amgen
Urea Cycle Disorder
Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)
THRIVE is an observational study that will collect information on patients with UCDs. THRIVE will follow enrolled participants for up to 10 years.
- Trial name
- THRIVE (NCT01948427)
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- Amgen
Urea Cycle Disorder
A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
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.
- Trial name
- NCT02246218
- Testing
- RAVICTI
- Where
- 17 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Amgen
Urea Cycle Disorder
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)
This is a randomized, controlled, open-label parallel arm study to assess the safety, tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to Sodium phenylbutyrate (NaPBA) in urea cycle disorder subjects…
- Trial name
- NCT03335488
- Testing
- RAVICTI, NaPBA
- Where
- 11 sites in United States, Italy and 2 more
- Volunteers
- 16 people
- Sponsor
- Amgen
Thyroid Eye Disease, Chronic (Inactive) Thyroid Eye Disease
A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
The overall objective is to investigate the efficacy, safety and tolerability of TEPEZZA® in participants with chronic (inactive) TED (thyroid eye disease). Approximately 57 participants will be enrolled.
- Trial name
- NCT04583735
- Testing
- TEPEZZA
- Where
- 12 sites in United States
- Volunteers
- 62 people
- Sponsor
- Amgen
Thyroid Eye Disease
Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study
The overall objective is to evaluate the safety and efficacy of teprotumumab in the treatment of thyroid eye disease (TED) in participants who participated in the lead-in study HZNP-TEP-301 (NCT03298867; OPTIC) and who were…
- Trial name
- OPTIC-X (NCT03461211)
- Testing
- Teprotumumab
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 51 people
- Sponsor
- Amgen
Diffuse Cutaneous Systemic Sclerosis
A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
The overall objective is to investigate the safety, tolerability and effect on insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of TEPEZZA (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody…
- Trial name
- NCT04478994
- Testing
- TEPEZZA
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Amgen
Active Systemic Lupus Erythematosus
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.
- Trial name
- NCT04680637
- Testing
- Efavaleukin Alfa, Standard of Care
- Where
- 150 sites in United States, Austria and 17 more
- Volunteers
- 168 people
- Sponsor
- Amgen
Uncontrolled Gout
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped…
- Trial name
- NCT04772313
- Testing
- Pegloticase, Methotrexate (MTX)
- Where
- 15 sites in United States
- Volunteers
- 11 people
- Sponsor
- Amgen
Gout
Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
The overall objective of the study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to enhance the response rate seen with pegloticase alone…
- Trial name
- MIRROR OL (NCT03635957)
- Testing
- Pegloticase, Methotrexate (MTX), Standard Gout Flare Prophylaxis
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Amgen
Gout
Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the…
- Trial name
- MIRROR RCT (NCT03994731)
- Testing
- Pegloticase, methotrexate, folic acid
- Where
- 60 sites in United States
- Volunteers
- 152 people
- Sponsor
- Amgen
Uncontrolled Gout, Kidney Transplant
Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
The primary objective of this study is to evaluate the effect of pegloticase on the response rate of sustained serum uric acid (sUA) reduction to sUA < 6 mg/dL during Month 6 of treatment.
- Trial name
- NCT04087720
- Testing
- Pegloticase
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Amgen
Highly Sensitized Patients on Waiting List for Kidney Transplantation
Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
Viela Bio is conducting an open-label, randomized study of inebilizumab, VIB4920, or the combination as part of a multi-center study in highly sensitized patients on the deceased donor waiting list for kidney transplantation.
- Trial name
- NCT04174677
- Testing
- Inebilizumab, VIB4920, Inebilzumab+VIB4920
- Where
- 2 sites in United States
- Sponsor
- Amgen
Thyroid Eye Disease
A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease
The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.
- Trial name
- NCT06389578
- Testing
- Teprotumumab
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Amgen
Healthy
A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)
To determine the safety and tolerability of single oral doses of HPN-100 as a formulation (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy male subjects.
- Trial name
- NCT00977600
- Testing
- HPN-100, Ammonul, Buphenyl
- Where
- Ukraine
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Hepatic Encephalopathy, Urea Cycle Disorders
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
The purpose of this study is to determine the safety and tolerability of GT4P administered orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic impairment with cirrhosis (Child-Pugh scores of…
- Trial name
- NCT00986895
- Testing
- HPN-100
- Where
- 2 sites in Ukraine
- Volunteers
- 32 people
- Sponsor
- Amgen
Drug Toxicity
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Arm 1: Primary Objective: To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: To assess the effects of steady-state levels of HPN-100 metabolites (4…
- Trial name
- NCT01135680
- Testing
- HPN-100, Moxifloxacin
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Amgen
Thyroid Eye Disease, Graves' Orbitopathy
Expanded Access Protocol of Teprotumumab (HZN-001) for Patients With Active Thyroid Eye Disease
This is an expanded access protocol intended to provide access to teprotumumab for the treatment of up to 60 patients in the United States with active moderate to severe thyroid eye disease where there is no comparable or…
- Trial name
- EAP (NCT04040894)
- Testing
- Teprotumumab
- Where
- 8 sites in United States
- Sponsor
- Amgen
Migraine
Biomarker and Genetic Predictors of Erenumab Treatment Response
To explore the relationship between clinical response to erenumab and genetic biomarkers
- Trial name
- INTERROGATE (NCT04265755)
- Testing
- Erenumab
- Where
- 2 sites in Denmark, Iceland
- Volunteers
- 1,406 people
- Sponsor
- Amgen
Hypercholesterolaemia
Chart Review of Repatha® in Subjects With Hyperlipidaemia
Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.
- Trial name
- HEYMANS (NCT02770131)
- Where
- 183 sites in Austria, Belgium and 10 more
- Volunteers
- 1,986 people
- Sponsor
- Amgen
Psoriasis
Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain
Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology.
- Trial name
- APPROPIATE (NCT03539419)
- Where
- 58 sites in Spain
- Volunteers
- 153 people
- Sponsor
- Amgen