Clinical trials: sponsored by Hoffmann-La Roche
Hepatocellular Carcinoma
A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome…
- Trial name
- NCT04712643
- Testing
- Atezolizumab, Becavizumab, Transarterial chemoembolization (TACE)
- Where
- 40 sites in China, Japan
- Volunteers
- 342 people
- Sponsor
- Hoffmann-La Roche
Hemophilia A
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital…
- Trial name
- ZEBRHA 1 (NCT07416526)
- Testing
- NXT007, Human Coagulation Factor VIII
- Where
- 36 sites in United States, Argentina and 16 more
- Volunteers
- 138 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor…
- Trial name
- INAVO121 (NCT05646862)
- Testing
- Inavolisib, Fulvestrant, Alpelisib
- Where
- 210 sites in United States, Argentina and 18 more
- Volunteers
- 420 people
- Sponsor
- Hoffmann-La Roche
Urothelial Cancer
A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer
This study will evaluate the safety of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are…
- Trial name
- NCT05645692
- Testing
- Atezolizumab, Tobemstomig, Tiragolumab
- Where
- 56 sites in United States, Australia and 13 more
- Volunteers
- 204 people
- Sponsor
- Hoffmann-La Roche
Atopic Dermatitis
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
- Trial name
- Velarite-LTE (NCT07223697)
- Testing
- Afimkibart
- Where
- 31 sites in United States, Brazil and 5 more
- Volunteers
- 120 people
- Sponsor
- Hoffmann-La Roche
Paroxysmal Nocturnal Hemoglobinuria
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.
- Trial name
- COMMODORE 1 (NCT04432584)
- Testing
- Crovalimab, Eculizumab
- Where
- 80 sites in United States, Belgium and 22 more
- Volunteers
- 190 people
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight
A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult…
- Trial name
- NCT07081958
- Testing
- RO7795081
- Where
- 36 sites in United States
- Volunteers
- 352 people
- Sponsor
- Hoffmann-La Roche
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime.
- Trial name
- NCT06704672
- Testing
- Accu-Chek SmartGuide CGM Solution, Accu-Chek SmartGuide Sensor and Blinded Apps, SMBG Device
- Where
- 20 sites in Poland, Turkey (Türkiye)
- Volunteers
- 270 people
- Sponsor
- Hoffmann-La Roche
Severe Hemophilia A, Moderate Hemophilia A
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and <70 years…
- Trial name
- Beyond ABR (NCT05181618)
- Testing
- Emicizumab
- Where
- 26 sites in United States, Brazil and 10 more
- Volunteers
- 136 people
- Sponsor
- Hoffmann-La Roche
Age-Related Macular Degeneration
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells.
- Trial name
- NCT02286089
- Testing
- OpRegen
- Where
- 7 sites in United States, Israel
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
- Trial name
- NCT06419374
- Testing
- Pegozafermin
- Where
- 330 sites in United States, Argentina and 23 more
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
Influenza
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' <12…
- Trial name
- Pebblestone (NCT06094010)
- Testing
- Baloxavir Marboxil
- Where
- 51 sites in United States, Bulgaria and 2 more
- Volunteers
- 1,100 people
- Sponsor
- Hoffmann-La Roche
Type 2 Diabetes Mellitus
A Clinical Study to Evaluate the Effects of Enicepatide Versus Tirzepatide in Participants With Type 2 Diabetes and Inadequate Blood Sugar Control on Oral Glucose-Lowering Medications
The study will evaluate the efficacy and safety of enicepatide, a glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide receptor (GLP-1/GIP) receptor agonist (RA), compared with tirzepatide among participants with…
- Trial name
- ENI-SPIRE-2 (NCT07889648)
- Testing
- Enicepatide, Tirzepatide
- Volunteers
- 948 people
- Sponsor
- Hoffmann-La Roche
Influenza, Human, Respiratory Tract Infections
A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in…
- Conditions
- Influenza, Human, Respiratory Tract Infections, Post-exposure Prophylaxis
- Trial name
- Pearlstone (NCT07827599)
- Testing
- Baloxavir marboxil
- Where
- 8 sites in China
- Volunteers
- 325 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Cancer
A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during…
- Trial name
- IMbrella B (NCT03768063)
- Testing
- Atezolizumab, Bevacizumab, Alectinib
- Where
- 80 sites in United States, Australia and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene…
- Trial name
- HINALEA 2 (NCT05861999)
- Testing
- Risdiplam
- Where
- 17 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Diabetes Type II
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.
- Trial name
- NCT07748208
- Testing
- Inavolisib, Fulvestrant, Palbociclib
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease (COPD), Healthy Participants
A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
This study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of single and multiple doses of RO7830698 in healthy participants and participants with chronic obstructive…
- Trial name
- NCT07822334
- Testing
- RO7830698
- Where
- United Kingdom
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Locally Advanced or Metastatic Solid Tumors
A Study of RO7821657 in Participants With Solid Tumors
The aim of this study is to characterize the safety and tolerability of RO7821657, describe its pharmacokinetics (PK), and evaluate pharmacodynamic and biomarker effects to support selection of the recommended Phase 2 dose(s)…
- Trial name
- NCT07883577
- Testing
- RO7821657
- Volunteers
- 405 people
- Sponsor
- Hoffmann-La Roche
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