Clinical trials: sponsored by Hoffmann-La Roche
Breast Cancer
A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This non-randomized, multicenter, open-label study will assess the safety and efficacy of subcutaneously administered trastuzumab in participants with early and locally advanced HER2-positive breast cancer in two sequential…
- Trial name
- SCHEARLY (NCT01940497)
- Testing
- Doxorubicin, Docetaxel, Paclitaxel
- Where
- 54 sites in Italy
- Volunteers
- 240 people
- Sponsor
- Hoffmann-La Roche
Lymphoma, B-Cell, Lymphoma, Follicular
An Observational Study of Patients With Malignant Lymphomas Treated With MabThera® SC in Everyday Clinical Practice
This observational study aims to assess the therapeutic responsiveness of MabThera SC in patients with malignant lymphomas under everyday clinical practice conditions.
- Trial name
- NCT02240316
- Where
- Germany
- Volunteers
- 688 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive…
- Trial name
- PERTAIN (NCT01491737)
- Testing
- Pertuzumab, Trastuzumab, Aromatase Inhibitor
- Where
- 82 sites in United States, Brazil and 6 more
- Volunteers
- 258 people
- Sponsor
- Hoffmann-La Roche
Gynecologic Neoplasms
A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer
This is a Phase Ib, open-label, non-randomized study in patients with previously treated advanced ovarian or endometrial cancer (Part 1) and platinum-sensitive ovarian cancer or triple-negative breast cancer (TNBC) (Part 2) to…
- Trial name
- NCT03101280
- Testing
- Atezolizumab, Rucaparib
- Where
- 11 sites in Australia, France and 2 more
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche
Spinal Muscular Atrophy
A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants
This will be a Phase I, 2-part, open-label, non-randomized study to investigate the safety, tolerability, and pharmacokinetics (PK) of a multiple-dosing regimen of risdiplam (Part 1) and the effect of risdiplam on the PK of…
- Trial name
- NCT03988907
- Testing
- Risdiplam, Midazolam
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Autism Spectrum Disorder
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder
This was a Phase Ib, multicenter, open-label study in children 2-4 years old with autism spectrum disorder (ASD) to investigate the pharmacokinetics, safety, and tolerability of an oral dose of balovaptan once a day (QD).
- Trial name
- NCT04049578
- Testing
- Balovaptan
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Hoffmann-La Roche
Basal Cell Carcinoma
A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)
This prospective, observational, cohort study is designed to assess the effectiveness and safety outcomes of vismodegib and to assess actual day-to-day disease and participant management by the physician.
- Trial name
- ROSETT (NCT02371967)
- Testing
- Vismodegib
- Where
- 4 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Diabetic Macular Edema
A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME).
- Trial name
- BOULEVARD (NCT02699450)
- Testing
- Faricimab, Ranibizumab
- Where
- 60 sites in United States
- Volunteers
- 229 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line…
- Trial name
- PERUSE (NCT01572038)
- Testing
- Docetaxel, Nab-paclitaxel, Paclitaxel
- Where
- 299 sites in Algeria, Argentina and 37 more
- Volunteers
- 1,436 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
Study of Tocilizumab (RoActemre) Administered Subcutaneously in Participants With Rheumatoid Arthritis in Everyday Clinical Practice
ARATA is a prospective, non-interventional, multicenter, observational study in Germany to evaluate the long-term effectiveness and tolerability of subcutaneously administered tocilizumab in participants with rheumatoid arthritis…
- Trial name
- ARATA (NCT02251860)
- Where
- Germany
- Volunteers
- 1,454 people
- Sponsor
- Hoffmann-La Roche
Giant Cell Arteritis
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who subsequently have flare or persisting…
- Trial name
- NCT03202368
- Testing
- Tocilizumab
- Where
- 3 sites in France
- Volunteers
- 3 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years
This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to…
- Trial name
- NCT01810393
- Testing
- Trastuzumab
- Where
- 61 sites in France
- Volunteers
- 114 people
- Sponsor
- Hoffmann-La Roche
Solid Tumors
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
This study was to determine the maximum-tolerated dose (MTD) and/or the optimal biological dose (OBD) as well as the optimal schedule for intravenous (IV) and subcutaneous (SC) administrations of RO7172508 as monotherapy, with or…
- Trial name
- NCT03539484
- Testing
- RO7172508, Obinutuzumab, Tocilizumab
- Where
- 6 sites in Belgium, Canada and 2 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Solid Cancers
A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors
This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic…
- Trial name
- NCT02323191
- Testing
- Atezolizumab, Emactuzumab
- Where
- 12 sites in United States, Belgium and 2 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
Pediatric Immuno-Tolerant Chronic Hepatitis B
A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase
This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus lamivudine or entecavir compared with an untreated…
- Trial name
- NCT02263079
- Testing
- Entecavir, Lamivudine, Pegylated Interferon Alfa-2A
- Where
- 25 sites in United States, Australia and 10 more
- Volunteers
- 62 people
- Sponsor
- Hoffmann-La Roche
Idiopathic Pulmonary Fibrosis
Quality of Life Study in Participants With IPF Under Pirfenidone Treatment
This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).
- Trial name
- PNEUMON (NCT03115619)
- Testing
- Pirfenidone
- Where
- 7 sites in Greece
- Volunteers
- 102 people
- Sponsor
- Hoffmann-La Roche
Influenza
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in children during the flu season. Children who would benefit from influenza prophylaxis when influenza is circulating in the community…
- Trial name
- NCT00412555
- Testing
- oseltamivir [Tamiflu]
- Where
- 6 sites in United States, Canada and 1 more
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Lymphoma
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL.
- Trial name
- NCT01889069
- Testing
- Rituximab, Cyclophosphamide, Vincristine
- Where
- 39 sites in Italy
- Volunteers
- 159 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
- Trial name
- NCT03959332
- Testing
- Baloxavir Marboxil
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
High Grade Glioma
A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma
This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared…
- Trial name
- NCT01390948
- Testing
- Bevacizumab, Radiotherapy, Temozolomide (TMZ)
- Where
- 53 sites in Australia, Austria and 12 more
- Volunteers
- 124 people
- Sponsor
- Hoffmann-La Roche
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