Clinical trials: completed, 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.
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.
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.
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.
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.
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.
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.
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.
Cystic Fibrosis
A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease
This is an observational study to be conducted at approximately 25 sites in the United States. Approximately 25 subjects with severe obstructive CF lung disease (FVC <40% predicted) will be enrolled.
- Trial name
- NCT00311506
- Volunteers
- 25 people
- Sponsor
- Genentech, Inc.
Asthma
A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
This study is a multicenter, prospective, observational cohort study of ~5000 Xolair-treated and ~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an…
- Trial name
- NCT00252135
- Volunteers
- 8,023 people
- Sponsor
- Genentech, Inc.
Growth Disorders
National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin
The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin…
- Trial name
- NCT00097539
- Testing
- Somatrem, Somatropin
- Volunteers
- 65,205 people
- Sponsor
- Genentech, Inc.
Acute Myocardial Infarction
An Observational Study of TNKase in Patients Enrolled in the National Registry of Myocardial Infarction 4 and 5 (POST)
The POST study comprised patients whose data were entered into the NRMI 4 and 5 databases. NRMI is a prospective, observational study of patients presenting with AMI in the United States.
- Trial name
- NCT00669045
- Volunteers
- 253,668 people
- Sponsor
- Genentech, Inc.
Dysfunctional Hemodialysis Catheters
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters
This was a Phase III, open-label study conducted at 44 centers in the United States, Canada, and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.
- Trial name
- TROPICS 4 (NCT00396253)
- Testing
- Tenecteplase
- Volunteers
- 223 people
- Sponsor
- Genentech, Inc.
Metastatic Breast Cancer
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously…
- Trial name
- NCT00932373
- Testing
- trastuzumab-MCC-DM1
- Volunteers
- 54 people
- Sponsor
- Genentech, Inc.
Psoriasis
A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)
This was a multicenter, prospective, 5-year surveillance study of approximately 5000 Raptiva-treated patients and approximately 500 non-Raptiva treated patients (formerly 2500 comparison patients who were treated with a biologic…
- Trial name
- RESPONSE (NCT00096928)
- Where
- 182 sites in United States
- Volunteers
- 1,846 people
- Sponsor
- Genentech, Inc.
Solid Cancers
A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study
This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent…
- Trial name
- NCT00096941
- Testing
- Pertuzumab
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.