Clinical trials: sponsored by Sanofi
Hypercholesterolemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment…
- Trial name
- NCT03510715
- Testing
- Alirocumab SAR236553 (REGN727), Atorvastatin, Simvastatin
- Where
- 10 sites in Brazil, Canada and 8 more
- Volunteers
- 18 people
- Sponsor
- Sanofi
Solid Tumors, Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter
A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma
This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A in solid tumors included the dose escalation phase for evaluating the safety and tolerability profile of…
- Trial name
- NCT02608125
- Testing
- PRN1371
- Where
- 12 sites in United States, Spain
- Volunteers
- 45 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Hemophilia A, Hemophilia B
A Phase 1 Study of an Investigational Drug, ALN-AT3SC, in Healthy Volunteers and Hemophilia A or B Patients
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of ALN-AT3SC in healthy volunteers and Hemophilia A or B patients.
- Trial name
- NCT02035605
- Testing
- ALN-AT3SC, Sterile Normal Saline (0.9% NaCl)
- Where
- 14 sites in United States, Bulgaria and 3 more
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Sanofi
Lymphoma, Non-Hodgkin, HIV Infections
A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma
To estimate the response rate, response duration, clinical benefit, and toxicity of mitoguazone dihydrochloride (MGBG) in patients with AIDS-related refractory or relapsing non-Hodgkin's lymphoma (NHL).
- Trial name
- NCT00002348
- Testing
- Mitoguazone
- Where
- United States
- Sponsor
- Genzyme, a Sanofi Company
Fabry Disease
A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease
No investigational drug will be administered in this study for the treatment of Fabry disease. This will be a multicenter, multinational, non-treatment, cross-sectional study of young male patients with Fabry disease who have not…
- Trial name
- NCT01839526
- Testing
- Iohexol
- Where
- 22 sites in United States, Argentina and 12 more
- Volunteers
- 39 people
- Sponsor
- Genzyme, a Sanofi Company
Neoplasm Malignant
A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
Primary Objective: To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma.
- Trial name
- NCT01596270
- Testing
- SAR245409
- Where
- 3 sites in United States
- Volunteers
- 49 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs
Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus.
- Trial name
- LIXILAN JP-L (NCT02752412)
- Testing
- Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine U100 (HOE901), Metformin
- Where
- 122 sites in Japan
- Volunteers
- 513 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes.
- Trial name
- LIXILAN JP-O2 (NCT02752828)
- Testing
- Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Oral anti-diabetic drugs
- Where
- 113 sites in Japan
- Volunteers
- 521 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
Primary Objective: To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT02713477
- Testing
- Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010, Insulin glargine HOE901
- Where
- Japan
- Volunteers
- 20 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
Primary Objective: To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus.
- Trial name
- LIXILAN JP-O1 (NCT02749890)
- Testing
- Insulin glargine/Lixisenatide (HOE901/AVE0010), Lixisenatide (AVE0010), Oral anti-diabetic drugs
- Where
- 61 sites in Japan
- Volunteers
- 321 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in…
- Trial name
- SENIOR (NCT02320721)
- Testing
- Insulin Glargine (HOE901 - U300), Insulin Glargine (HOE901 - U100), Background therapy
- Where
- 162 sites in United States, Argentina and 16 more
- Volunteers
- 1,014 people
- Sponsor
- Sanofi
Pregnancy, Influenza
Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry
The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and…
- Trial name
- NCT01945424
- Testing
- Quadrivalent Influenza Vaccine (QIV)
- Where
- 5 sites in United States
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pregnancy, Influenza
Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry
The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect to collect and analyze information on vaccine…
- Trial name
- NCT02554409
- Testing
- Quadrivalent Intradermal Influenza Vaccine (QIV)
- Where
- 5 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Fabry Disease
Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry Disease
Primary Objective: To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants diagnosed with Fabry disease.
- Trial name
- NCT02228460
- Testing
- GZ/SAR402671
- Where
- 8 sites in United States, France and 3 more
- Volunteers
- 11 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
Primary Objective: To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and…
- Trial name
- SINUS-52 (NCT02898454)
- Testing
- Dupilumab SAR231893 (REGN668), Mometasone furoate nasal spray
- Where
- 123 sites in United States, Argentina and 12 more
- Volunteers
- 448 people
- Sponsor
- Sanofi
Respiratory Syncytial Virus Lower Respiratory Tract Infection
Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI).
- Trial name
- Respire (NCT02979431)
- Testing
- ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg, ALX-0171 9.0 mg/kg
- Where
- 74 sites in Belgium, Bulgaria and 15 more
- Volunteers
- 180 people
- Sponsor
- Ablynx, a Sanofi company
Asthma
Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma
Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma.
- Trial name
- VENTURE (NCT02528214)
- Testing
- Dupilumab, Oral corticosteroid therapy (prednisone/prednisolone), Inhaled corticosteroid (ICS) therapy
- Where
- 80 sites in United States, Argentina and 15 more
- Volunteers
- 210 people
- Sponsor
- Sanofi
Hypercholesterolemia
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24…
- Trial name
- ODYSSEY EAST (NCT02715726)
- Testing
- Alirocumab, ezetimibe, atorvastatin
- Where
- 62 sites in China, India and 1 more
- Volunteers
- 615 people
- Sponsor
- Sanofi
Diabetes Mellitus, Type 2
A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
Primary Objective: Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (<8% if age >=65 years or with defined…
- Trial name
- NCT02451137
- Testing
- Insulin glargine, 300 U/ml, Insulin glargine, 100 U/ml, Insulin detemir
- Where
- 427 sites in United States, Canada
- Volunteers
- 3,304 people
- Sponsor
- Sanofi
Hypercholesterolaemia
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Primary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings.
- Trial name
- NCT03415178
- Testing
- Alirocumab SAR236553, Current auto-injector device (AI), New auto-injector device (SYDNEY)
- Where
- 13 sites in United States
- Volunteers
- 69 people
- Sponsor
- Sanofi
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