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Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function

Phase 1
Completed
Conditions
Renal Insufficiency
Healthy Volunteers
Interventions
First Posted Date
2018-09-05
Last Posted Date
2019-10-22
Lead Sponsor
Guerbet
Target Recruit Count
40
Registration Number
NCT03657784
Locations
🇲🇩

Republican Clinical Hospital, Arensia EM Unit, Chisinau, Moldova, Republic of

🇷🇴

Arensia Phase I unit "Carol Davila" Nephrology Hospital, Bucharest, Romania

Cardiac Safety Evaluation of P03277

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: P03277 0.1 mmol/kg
Drug: NaCl 0.9%
Drug: P03277 0.3 mmol/kg
First Posted Date
2018-09-05
Last Posted Date
2022-07-18
Lead Sponsor
Guerbet
Target Recruit Count
48
Registration Number
NCT03657264
Locations
🇧🇪

Clinical Pharmacology unit, SGS-Life Science Service, Antwerpen, Belgium

Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

Phase 1
Completed
Conditions
Healthy Volunteers
Brain Lesion
Interventions
Drug: Placebo
First Posted Date
2018-07-27
Last Posted Date
2021-05-14
Lead Sponsor
Guerbet
Target Recruit Count
142
Registration Number
NCT03603106
Locations
🇧🇪

Clinical Pharmacology unit, SGS Life Science Services, Antwerpen, Belgium

Post-marketing Surveillance Study for Evaluation of Dotarem Safety

Completed
Conditions
Contrast-enhanced MRI With Dotarem
Interventions
Procedure: MRI with Dotarem
First Posted Date
2017-02-09
Last Posted Date
2017-05-02
Lead Sponsor
Guerbet
Target Recruit Count
44456
Registration Number
NCT03048006

Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography

Completed
Conditions
MR Mammography With Dotarem
Interventions
Procedure: MR mammography with Dotarem
First Posted Date
2017-02-02
Last Posted Date
2017-05-02
Lead Sponsor
Guerbet
Target Recruit Count
1537
Registration Number
NCT03041298

Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis

Phase 2
Completed
Conditions
HepatoCellular Carcinoma
Chronic Liver Disease
Interventions
Drug: P03277 at 0.1 mmol/kg
Drug: P03277 at 0.05 mmol/kg
First Posted Date
2016-11-25
Last Posted Date
2021-10-26
Lead Sponsor
Guerbet
Target Recruit Count
41
Registration Number
NCT02973516
Locations
🇫🇷

CHU Angers, Angers, France

🇫🇷

Hôpital Beaujon, Clichy, France

P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Phase 2
Completed
Conditions
CNS Lesion
Blood Brain Barrier Defect
Interventions
First Posted Date
2015-12-17
Last Posted Date
2021-10-25
Lead Sponsor
Guerbet
Target Recruit Count
312
Registration Number
NCT02633501
Locations
🇮🇹

Ospedali Riuniti di Ancona, Ancona, Italy

🇮🇹

AO S. Andrea Universita La Sapienza, Roma, Italy

🇭🇺

Pecsi Tudomany Egyetem Klinikai kozpont Idegsebeszeti Klinica, Pécs, Hungary

and more 25 locations

Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.

Phase 4
Conditions
Angiosarcoma
Arteriovenous Malformation
Hemangioendothelioma
Congenital Hemangioma
Interventions
First Posted Date
2015-12-09
Last Posted Date
2020-02-19
Lead Sponsor
Guerbet
Target Recruit Count
125
Registration Number
NCT02625389
Locations
🇮🇳

Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital, Gurgaon, Haryana, India

🇮🇳

Christian Medical College Hospital, Vellore, Tamil Nadu, India

DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years

Phase 4
Completed
Conditions
Magnetic Resonance Imaging
Interventions
First Posted Date
2015-04-08
Last Posted Date
2017-03-09
Lead Sponsor
Guerbet
Target Recruit Count
51
Registration Number
NCT02411201
Locations
🇫🇷

CHU, Bordeaux, France

🇵🇱

Uniwersytecki Szpital Dziecięcy w Lublinie, Lublin, Poland

🇫🇷

Hôpital de Hautepierre, Strasbourg, France

and more 6 locations

Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors

Phase 4
Completed
Conditions
Primary Brain Tumor
Interventions
Drug: Gadovist®/Gadavist®
First Posted Date
2014-01-13
Last Posted Date
2016-12-30
Lead Sponsor
Guerbet
Target Recruit Count
279
Registration Number
NCT02034708
Locations
🇺🇸

UVM MRI Center for Biomedical Imaging, Burlington, Vermont, United States

🇺🇸

University of Arizona Medical Center, Tucson, Arizona, United States

🇺🇸

University of Washington Medical Center, Seattle, Washington, United States

and more 29 locations
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