Clinical trials: sponsored by Hoffmann-La Roche
Anemia
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia.
- Trial name
- NCT00737464
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 17 sites in India
- Volunteers
- 132 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia.
- Trial name
- NCT00661505
- Testing
- methoxy polyethylene glycol-epoetin beta
- Where
- 20 sites in Turkey (Türkiye)
- Volunteers
- 132 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus Type 1
Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes
This study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump system with multiple daily injections (MDI) therapy.
- Trial name
- Insight Kids (NCT02403375)
- Testing
- Accu-Chek Insight Pump System
- Where
- 9 sites in Austria, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 2
A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients.
This study is a German, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated PDM care by measuring HbA1c levels in patients with Type 2…
- Trial name
- PDM-ProValueGP (NCT02268929)
- Testing
- Accu-Chek Smart Pix Software, Accu-Chek Smart Pix readout Device
- Where
- 50 sites in Germany
- Volunteers
- 414 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteer
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RO6889450 in Healthy Volunteers
This randomized, single center, adaptive single ascending dose (Part 1) and multiple ascending dose (Part 2) study is designed to assess the safety, tolerability, pharmacokinetic, and pharmacodynamics following an oral…
- Trial name
- NCT02699372
- Testing
- RO6889450
- Where
- Netherlands
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Juvenile Idiopathic Arthritis
A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis
This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA).
- Trial name
- NCT01904292
- Testing
- Tocilizumab
- Where
- 42 sites in United States, Argentina and 10 more
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma, Neoplasms
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and…
- Trial name
- NCT01524978
- Testing
- cetuximab, vemurafenib
- Where
- 34 sites in United States, China and 4 more
- Volunteers
- 208 people
- Sponsor
- Hoffmann-La Roche
Idiopathic Pulmonary Fibrosis
Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada
This is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and…
- Trial name
- NCT02552849
- Testing
- No intervention
- Where
- 26 sites in Canada
- Volunteers
- 305 people
- Sponsor
- Hoffmann-La Roche
Type II Diabetes Mellitus
A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
This study is a German, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated PDM care by measuring HbA1c levels in patients with Type 2…
- Trial name
- PDMProValueDSP (NCT02156349)
- Testing
- Accu-Chek Smart Pix Software, Accu-Chek Smart Pix readout Device
- Where
- 50 sites in Germany
- Volunteers
- 558 people
- Sponsor
- Hoffmann-La Roche
Diffuse Large B-Cell Lymphoma
An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL).
- Trial name
- NCT01340443
- Where
- 24 sites in China
- Volunteers
- 314 people
- Sponsor
- Hoffmann-La Roche
Malignant Melanoma, Cancer
Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies
The purpose of this study is to characterize the pharmacokinetics (PK) of a single intravenous (IV) infusion of 14C-labeled vemurafenib administered shortly after an oral dose of vemurafenib and following multiple oral doses of…
- Trial name
- NCT02441465
- Testing
- Vemurafenib, 14C-Labeled Vemurafenib
- Where
- Hungary
- Volunteers
- 6 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia.
- Trial name
- NCT01066000
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 12 sites in Indonesia
- Volunteers
- 33 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib
This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug interaction study in healthy subjects.
- Trial name
- NCT03222310
- Testing
- Ipatasertib, Itraconazole
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Bronchitis
A Non-Interventional Safety Study of Balsamic Bactrim
This is a pilot, observational and multicentric study of safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis.
- Trial name
- NCT02902640
- Testing
- Guaifenesin, Sulfamethoxazole, Trimethoprim
- Where
- 4 sites in Peru
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 1
ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
This post-market, interventional, prospective, single arm, the United States (US) based multi-center study will assess the change in treatment satisfaction of participants who utilize the ACCU-CHEK Connect Diabetes Management…
- Trial name
- NCT02600845
- Testing
- ACCU-CHEK
- Where
- 11 sites in United States
- Volunteers
- 122 people
- Sponsor
- Hoffmann-La Roche
Ovarian Cancer
A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary…
- Trial name
- NCT00937560
- Testing
- Bevacizumab, Paclitaxel, Carboplatin
- Where
- 55 sites in Brazil, France and 7 more
- Volunteers
- 190 people
- Sponsor
- Hoffmann-La Roche
Alzheimer's Disease
Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants
This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who previously participated in study BP29409 (NCT02187627).
- Trial name
- NCT02792179
- Testing
- [18F]RO6958948
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin
Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy…
- Trial name
- NCT02508090
- Where
- Puerto Rico
- Volunteers
- 10 people
- Sponsor
- Hoffmann-La Roche
Idiopathic Pulmonary Fibrosis
A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated…
- Trial name
- ISLAND2 (NCT02648048)
- Testing
- Pirfenidone, Vismodegib
- Where
- 15 sites in United States, Germany
- Volunteers
- 21 people
- Sponsor
- Hoffmann-La Roche
Down Syndrome
A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)
This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome.
- Trial name
- NCT02024789
- Testing
- RG1662
- Where
- 37 sites in United States, Argentina and 8 more
- Volunteers
- 173 people
- Sponsor
- Hoffmann-La Roche
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