Clinical trials: sponsored by Genentech, Inc.
Spinal Muscular Atrophy
Long-term Follow-up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA)
A multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the Evrysdi® U.S.
- Trial name
- WeSMA (NCT05232929)
- Testing
- Risdiplam
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 403 people
- Sponsor
- Genentech, Inc.
Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
The Mycophenolate Pregnancy Registry
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure.
- Trial name
- NCT01733082
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Genentech, Inc.
Inherited Retinal Dystrophy Due to RPE65 Mutations
Long-term Follow-up Study in Subjects Who Received Voretigene Neparvovec-rzyl (AAV2-hRPE65v2)
Multi-site, non-randomized, observational study, for up to 15 years after subretinal AAV2-hRPE65v2 administration for each subject.
- Trial name
- NCT03602820
- Testing
- AAV2-hRPE65v2
- Volunteers
- 41 people
- Sponsor
- Genentech, Inc.
Peanut Hypersensitivity
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the…
- Trial name
- NCT00382148
- Testing
- omalizumab
- Volunteers
- 11 people
- Sponsor
- Genentech, Inc.
Colorectal Cancer, Non-Small Cell Lung Cancer
A Study of Avastin in Combination With Chemotherapy for Treatment of Colorectal Cancer and Non-Small Cell Lung Cancer (ARIES)
This is an observational study designed to follow patients with metastatic or locally advanced and unresectable CRC or locally advanced or metastatic NSCLC (excluding predominant squamous histology) who are receiving Avastin in…
- Trial name
- ARIES (NCT00388206)
- Volunteers
- 3,998 people
- Sponsor
- Genentech, Inc.
Hemophilia A
Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures
This Phase IV, multicenter study will evaluate whether participants with Hemophilia A (PwHA) with or without inhibitors receiving emicizumab prophylaxis can safely undergo minor surgical procedures without additional prophylactic…
- Trial name
- NCT03361137
- Testing
- Emicizumab
- Where
- 8 sites in United States
- Volunteers
- 14 people
- Sponsor
- Genentech, Inc.
Lupus Nephritis, Systemic Lupus Erythematosus
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant…
- Trial name
- BELONG (NCT00626197)
- Testing
- Corticosteroids, Cyclophosphamide, Mycophenolate Mofetil
- Volunteers
- 381 people
- Sponsor
- Genentech, Inc.
Muscular Atrophy, Spinal
An Expanded Access Program for Risdiplam in Participants With Spinal Muscular Atrophy (SMA)
This expanded access program (EAP) will provide access to risdiplam for eligible participants with Type 1 or Type 2 spinal muscular atrophy (SMA) before it is commercially available in the United States for the indication of SMA.
- Trial name
- NCT04256265
- Testing
- Risdiplam
- Where
- 29 sites in United States
- Sponsor
- Genentech, Inc.
Systemic Lupus Erythematosus
A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)
This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background…
- Trial name
- BEGIN (NCT00539838)
- Testing
- Prednisone, Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate), Methylprednisolone
- Volunteers
- 33 people
- Sponsor
- Genentech, Inc.
Lupus Erythematosus, Systemic
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive…
- Trial name
- EXPLORER (NCT00137969)
- Testing
- Rituximab, Prednisone, Acetaminophen
- Where
- 65 sites in United States, Canada
- Volunteers
- 262 people
- Sponsor
- Genentech, Inc.
Growth Hormone Deficiency
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH)…
- Trial name
- NCT02311894
- Testing
- Somatropin
- Where
- 33 sites in United States
- Volunteers
- 82 people
- Sponsor
- Genentech, Inc.
Hemophilia A
An Expanded Access Program of Emicizumab in Participants With Hemophilia A With Inhibitors
This open-label, multicenter expanded access program (EAP) is designed to provide emicizumab to eligible participants with hemophilia A with factor VIII (FVIII) inhibitors before it is commercially available in the United States…
- Trial name
- NCT03154437
- Testing
- Emicizumab
- Where
- 14 sites in United States
- Sponsor
- Genentech, Inc.
Urticaria
A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine…
- Trial name
- NCT02392624
- Testing
- Omalizumab
- Where
- 40 sites in United States
- Volunteers
- 206 people
- Sponsor
- Genentech, Inc.
Asthma
An Observational Study of the Use and Safety of Xolair® During Pregnancy
The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®.
- Trial name
- EXPECT (NCT00373061)
- Testing
- Xolair®
- Where
- United States
- Volunteers
- 309 people
- Sponsor
- Genentech, Inc.
Lupus Erythematosus, Systemic
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of…
- Trial name
- VOYAGER (NCT00381810)
- Testing
- Rituximab, Methylprednisolone, Acetaminophen
- Where
- 11 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.
Allergic Asthma
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis.
- Trial name
- X-PAND (NCT00813748)
- Testing
- Xolair
- Where
- 7 sites in United States
- Volunteers
- 118 people
- Sponsor
- Genentech, Inc.
Breast Cancer
An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)
This is a multicenter, prospective observational cohort study (OCS) designed to follow patients with locally recurrent or metastatic breast cancer in the United States.
- Trial name
- VIRGO (NCT00726661)
- Volunteers
- 1,287 people
- Sponsor
- Genentech, Inc.
Chronic Idiopathic Urticaria
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the…
- Trial name
- NCT00866788
- Testing
- omalizumab, H1 antihistamines, Diphenhydramine
- Volunteers
- 90 people
- Sponsor
- Genentech, Inc.
Asthma
A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a…
- Trial name
- EXACT (NCT00096954)
- Testing
- omalizumab (Xolair)
- Volunteers
- 333 people
- Sponsor
- Genentech, Inc.
Malignant Melanoma
Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E
This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in participants with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF…
- Trial name
- NCT01586195
- Testing
- Vemurafenib
- Where
- 15 sites in United States
- Volunteers
- 31 people
- Sponsor
- Genentech, Inc.