Clinical trials: sponsored by Hoffmann-La Roche
Bladder Cancer
Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants
This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of atezolizumab administered by intravenous (IV)…
- Trial name
- NCT02792192
- Testing
- Atezolizumab, Bacille Calmette-Guérin
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder
A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).
- Trial name
- NCT03504917
- Testing
- Balovaptan
- Where
- 51 sites in United States, Canada and 4 more
- Volunteers
- 322 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Small-Cell Lung
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared…
- Trial name
- IMpower150 (NCT02366143)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab, Carboplatin
- Where
- 240 sites in United States, Argentina and 24 more
- Volunteers
- 1,202 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant…
- Trial name
- BERENICE (NCT02132949)
- Testing
- 5-Fluorouracil, Cyclophosphamide, Docetaxel
- Where
- 80 sites in United States, Canada and 10 more
- Volunteers
- 401 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants…
- Trial name
- NCT00642967
- Testing
- Methoxy Polyethylene Glycol-epoetin Beta
- Where
- 69 sites in France
- Volunteers
- 127 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.
This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on…
- Trial name
- NCT00717821
- Testing
- Methoxy Polyethylene Glycol-epoetin Beta, Epoetin Beta, Darbepoetin Alfa
- Where
- 89 sites in France
- Volunteers
- 421 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus
A French Study to Evaluate the Usefulness of an Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus
This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve glycemic control in patients…
- Trial name
- NCT03445065
- Testing
- Eversense XL CGM System, Usual SMBG or FGM device used by participants
- Where
- 20 sites in France
- Volunteers
- 239 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 1
Participant-Reported Outcomes With the Accu-Chek® Solo Micropump System
This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction.
- Trial name
- PRO Solo (NCT03478969)
- Testing
- Accu-Chek® Solo micropump system, mylife™ OmniPod® Insulin Management System, Multiple Daily Injections (MDI) therapy
- Where
- 21 sites in Austria, Germany and 2 more
- Volunteers
- 181 people
- Sponsor
- Hoffmann-La Roche
Colitis, Ulcerative
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely…
- Trial name
- LAUREL (NCT02165215)
- Testing
- Etrolizumab
- Where
- 104 sites in United States, Brazil and 13 more
- Volunteers
- 359 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with…
- Trial name
- HICKORY (NCT02100696)
- Testing
- Etrozulimab
- Where
- 184 sites in United States, Argentina and 22 more
- Volunteers
- 609 people
- Sponsor
- Hoffmann-La Roche
Alzheimers Disease
A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants
Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy…
- Trial name
- NCT04023994
- Testing
- RO7126209
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Squamous Non-Small Cell Lung
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel…
- Trial name
- IMpower130 (NCT02367781)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin, Nab-Paclitaxel
- Where
- 132 sites in United States, Belgium and 6 more
- Volunteers
- 723 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active…
- Trial name
- HIBISCUS II (NCT02171429)
- Testing
- Adalimumab, Etrolizumab
- Where
- 90 sites in United States, Argentina and 17 more
- Volunteers
- 358 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active…
- Trial name
- HIBISCUS I (NCT02163759)
- Testing
- Adalimumab, Etrolizumab
- Where
- 88 sites in United States, Argentina and 12 more
- Volunteers
- 358 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor
A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or Other Treatments in Participants With Solid Tumors
This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel +…
- Trial name
- NCT02715531
- Testing
- 5-FU, Atezolizumab, Bevacizumab
- Where
- 30 sites in United States, Australia and 5 more
- Volunteers
- 243 people
- Sponsor
- Hoffmann-La Roche
COVID-19 Pneumonia
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19…
- Trial name
- COVACTA (NCT04320615)
- Testing
- Tocilizumab (TCZ)
- Where
- 62 sites in United States, Canada and 7 more
- Volunteers
- 452 people
- Sponsor
- Hoffmann-La Roche
Hemophilia A
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors
This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of prophylactic emicizumab treatment in participants previously treated with episodic or prophylactic bypassing agents.
- Trial name
- HAVEN 1 (NCT02622321)
- Testing
- Emicizumab, rFVIIa, aPCC
- Where
- 44 sites in United States, Australia and 12 more
- Volunteers
- 113 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Small Cell Lung
A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer
This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab…
- Trial name
- CATHAYA (NCT04611776)
- Testing
- Atezolizumab, Carboplatin, Cisplatin
- Sponsor
- Hoffmann-La Roche
Hemophilia A
A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors
This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at…
- Trial name
- STASEY (NCT03191799)
- Testing
- Emicizumab
- Where
- 72 sites in Australia, Belgium and 22 more
- Volunteers
- 195 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced Solid Tumors, Metastatic Solid Tumors
Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.
Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the…
- Trial name
- STARTRK-1 (NCT02097810)
- Testing
- Entrectinib
- Where
- 10 sites in United States, South Korea
- Volunteers
- 84 people
- Sponsor
- Hoffmann-La Roche
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