Clinical trials: Patient Safety
Pediatric Crohn's Disease
Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease
The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg…
- Trial name
- NCT01580670
- Testing
- TA-650
- Where
- 7 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Tanabe Pharma Corporation
Follicular Lymphoma
Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
To evaluate the effectiveness and safety of obinutuzumab in clinical routine in 1L FL measured by the % of relapse within 24 months from start of therapy.
- Trial name
- URBAN (NCT04034056)
- Testing
- Obinutuzumab
- Where
- 46 sites in Italy
- Volunteers
- 299 people
- Sponsor
- Hoffmann-La Roche
Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse
CT-011 MAb in DLBCL Patients Following ASCT
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease.
- Conditions
- Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse, Primary Mediastinal Large B-Cell Lymphoma
- Trial name
- NCT00532259
- Testing
- CT-011
- Where
- 27 sites in United States, India and 1 more
- Volunteers
- 72 people
- Sponsor
- CureTech Ltd
Sickle Cell Disease (SCD)
An Indian Multi-centric Phase IV Study to Assess the Safety of Crizanlizumab in Sickle Cell Disease Patients
Sickle cell disease (SCD) is a genetic blood disorder. Crizanlizumab is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in patients with SCD aged 16 years and older.
- Trial name
- NCT04662931
- Testing
- crizanlizumab
- Where
- 7 sites in India
- Volunteers
- 140 people
- Sponsor
- Novartis Pharmaceuticals
Myocardial Infarction
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)
- Trial name
- ERASE-MI (NCT00546260)
- Testing
- PRT060128 Potassium
- Where
- 31 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
COVID-19
Safety, Tolerability, and Treatment Effect of Belnacasan in Patients With COVID-19
The purpose of this trial is to assess the safety, tolerability and treatment effect of the orally administered Caspase-1 inhibitor, belnacasan, for the treatment of patients with mild to moderate COVID-19 and to generate proof…
- Trial name
- NCT05164120
- Testing
- Belnacasan
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MedStar Health
Hereditary Angioedema (HAE)
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.
- Trial name
- NCT00262080
- Testing
- ecallantide, Phosphate Buffer Saline (PBS),
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Shire
Asthma
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants…
- Trial name
- NCT01312961
- Testing
- Dupilumab, Fluticasone/Salmeterol combination therapy, Fluticasone monotherapy
- Where
- 50 sites in United States
- Volunteers
- 104 people
- Sponsor
- Sanofi
Plaque Psoriasis
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis.
- Trial name
- ESTEEM 2 (NCT01232283)
- Testing
- Apremilast, Topical or Phototherapy Therapy
- Where
- 46 sites in United States, Austria and 7 more
- Volunteers
- 413 people
- Sponsor
- Amgen
Metastatic Castrate-resistant Prostate Cancer, Adenocarcinoma, Prostate
Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients
This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253.
- Trial name
- NCT02987829
- Testing
- TRC253
- Where
- 5 sites in United States
- Volunteers
- 72 people
- Sponsor
- Tracon Pharmaceuticals Inc.
Carcinoma, Non-Small-Cell Lung, Colorectal Cancer
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or…
- Conditions
- Carcinoma, Non-Small-Cell Lung, Colorectal Cancer, Malignant Melanoma, Renal Cancer
- Trial name
- MDX1106-01 (NCT00441337)
- Testing
- MDX-1106
- Where
- 4 sites in United States
- Volunteers
- 39 people
- Sponsor
- Bristol-Myers Squibb
Melanoma, Cancer
Dose Escalation Study With Expansion to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of CCT3833
The study is a first in man, dose escalation study to evaluate the safety, tolerability and how the drug works in the body in patients with all solid tumours.
- Trial name
- PanRAF (NCT02437227)
- Testing
- CCT3833
- Where
- 2 sites in United Kingdom
- Volunteers
- 31 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Multiple Sclerosis
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan…
- Trial name
- NCT00654927
- Testing
- Fampridine-SR b.i.d. (Twice Daily)
- Where
- 22 sites in United States, Canada
- Volunteers
- 177 people
- Sponsor
- Acorda Therapeutics
Atopic Dermatitis
Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis
The purpose of the study is to compare the efficacy and safety of benralizumab versus placebo and to compare benralizumab dosing regimens during extension period.
- Trial name
- NCT04605094
- Testing
- Benralizumab
- Where
- 51 sites in United States, Australia and 6 more
- Volunteers
- 194 people
- Sponsor
- AstraZeneca
Obesity
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
- Trial name
- LBMI (NCT00580502)
- Testing
- LAP-BAND® Adjustable Gastric Band (LAGB®)
- Volunteers
- 50 people
- Sponsor
- NYU Langone Health
Epithelial Ovarian Cancer, Peritoneal Cancer
Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer
The purpose of this study is to determine the biologically active dose of entinostat, when given in combination with avelumab, that is safe and warrants further investigation.
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Trial name
- NCT02915523
- Testing
- entinostat, avelumab
- Where
- 12 sites in United States
- Volunteers
- 140 people
- Sponsor
- Syndax Pharmaceuticals
HIV-1 Infection
Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL
This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological success in virologically suppressed HIV-1…
- Trial name
- NCT02212379
- Testing
- raltegravir and etravirine
- Where
- 19 sites in France, Spain
- Volunteers
- 170 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Hepatocellular Carcinoma
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC).
- Trial name
- NCT01232296
- Testing
- dovitinib, sorafenib
- Where
- 24 sites in China, Hong Kong and 5 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Type 2 Diabetes Mellitus
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Primary Objective: To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes…
- Trial name
- AMPLITUDE-D (NCT03684642)
- Testing
- Efpeglenatide, Dulaglutide, Background therapy Metformin
- Where
- 45 sites in United States, Hungary and 2 more
- Volunteers
- 908 people
- Sponsor
- Sanofi
Uremic Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- NCT03422653
- Testing
- CR845 0.5 mcg/kg
- Where
- 57 sites in United States
- Volunteers
- 378 people
- Sponsor
- Cara Therapeutics, Inc.
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