Clinical trials: Patient Safety
Multiple Myeloma
Cyclophosphamide, VELCADE, DOXIL, and Dexamethasone, (CVDD) in Newly Diagnosed Patients With Multiple Myeloma (MM)
Cyclophosphamide is a chemotherapy agent with known activity in myeloma. The new regimen that we will test in this study is called CVDD and contains Cyclophosphamide with Bortezomib (VELCADE), Pegylated Liposomal Doxorubicin…
- Trial name
- NCT00750815
- Testing
- Cyclophosphamide, Bortezomib; Pegylated Liposomal Doxorubicin; Dexamethasone (VDD)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Polymyalgia Rheumatica, Inflammatory Diseases
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety…
- Trial name
- NCT01364389
- Testing
- AIN457, ACZ885, Prednisone
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Ovarian Neoplasms, Peritoneal Neoplasms
LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced…
- Trial name
- NCT01015118
- Testing
- Paclitaxel, BIBF 1120, Carboplatin
- Where
- 281 sites in United States, Australia and 20 more
- Volunteers
- 1,366 people
- Sponsor
- Boehringer Ingelheim
Epilepsy
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).
- Trial name
- NCT02316847
- Testing
- diazepam nasal spray
- Where
- 33 sites in United States
- Volunteers
- 126 people
- Sponsor
- Acorda Therapeutics
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in participants with ATTR amyloidosis with cardiomyopathy.
- Trial name
- NCT04153149
- Testing
- Vutrisiran, Sterile Normal Saline (0.9% NaCl)
- Where
- 121 sites in United States, Argentina and 31 more
- Volunteers
- 655 people
- Sponsor
- Alnylam Pharmaceuticals
Myelodysplastic Syndrome
Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study
This is an extension study to investigate long term safety and efficacy of SyB C-1101 when orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who have completed 6 cycles in the study 2012002…
- Trial name
- NCT02002936
- Testing
- SyB C-1101
- Where
- 4 sites in Japan
- Volunteers
- 1 people
- Sponsor
- SymBio Pharmaceuticals
Follicular Lymphoma, Lymphoma, Follicular
Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP.
- Trial name
- NCT00384111
- Testing
- Zevalin Therapeutic Regimen, R-CVP
- Where
- 6 sites in United States
- Volunteers
- 26 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
The purpose of this study is to determine whether ATIR is safe and effective in reducing transplant-related mortality and improving overall survival, when infused in patients with a hematologic malignancy following a T-cell…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT01794299
- Testing
- ATIR
- Where
- 8 sites in Belgium, Canada and 2 more
- Volunteers
- 31 people
- Sponsor
- Kiadis Pharma
Lymphoma, Mantle- Cell
Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy
This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy and who had received at least one prior…
- Trial name
- PILLAR-1 (NCT00702052)
- Testing
- Everolimus
- Where
- 31 sites in United States
- Volunteers
- 58 people
- Sponsor
- Novartis Pharmaceuticals
Alzheimer's Disease
Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease
This study evaluated the effect of 6 or 12 infusions of different doses of octagam (intravenous immunoglobulin [IVIG]) 10% on the reduction of amyloid beta peptide (Aβ) in cerebral spinal fluid (CSF) and on the increase of Aβ in…
- Trial name
- NCT00812565
- Testing
- octagam 10%
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Octapharma
Sickle Cell Disease
An Extension Study to Further Evaluate the Safety, Tolerability of GBT440 in Patients With Sickle Cell Disease Who Participated in the Study GBT440-001
This is an open label, single arm study which enrolled 5 subjects with SCD who previously participated in the GBT440-001 study (NCT02285088).
- Trial name
- NCT03041909
- Testing
- GBT440
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- Global Blood Therapeutics
Atopic Dermatitis (AD)
Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)
The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT01979016
- Testing
- Dupilumab, Background treatment
- Where
- 4 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Regeneron Pharmaceuticals
Invasive Pulmonary Aspergillosis
Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis.
- Trial name
- SCYNERGIA (NCT03672292)
- Testing
- SCY-078, Voriconazole
- Where
- 8 sites in United States, Belgium and 3 more
- Volunteers
- 22 people
- Sponsor
- Scynexis, Inc.
Coronary Heart Disease (CHD)
Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction
A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.
- Trial name
- GOLDILOX (NCT04610892)
- Testing
- MEDI6570
- Where
- 84 sites in United States, Australia and 9 more
- Volunteers
- 423 people
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT01590771
- Testing
- Sitagliptin, Gliclazide, Glimepiride
- Volunteers
- 498 people
- Sponsor
- Merck Sharp & Dohme LLC
Dry Eye
A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution…
- Trial name
- NCT03598699
- Testing
- AXR-159, Vehicle
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- AxeroVision, Inc.
HPV16 Associated Cervical Cancer
Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer
This study will be looking at what dose of the TA-CIN vaccine is safe and effective in patients with a history of HPV16-associated cervical cancer.
- Trial name
- NCT02405221
- Testing
- TA-CIN (arm), TA-CIN (thigh)
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Neoplasms, Triple-Negative Breast Cancer
A Study Of PF-06647263 In Patients With Advanced Solid Tumors
To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
- Trial name
- NCT02078752
- Testing
- PF-06647263
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Pfizer
Advanced Solid Tumors
This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors
This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients.
- Trial name
- NCT00932126
- Testing
- PF-03758309
- Where
- 3 sites in United States, Australia
- Volunteers
- 35 people
- Sponsor
- Pfizer
Postoperative Pain
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations.
- Trial name
- NCT00993226
- Testing
- SABER-Bupivacaine Treatment 1a, Bupivacaine HCl Treatment 1c, SABER-Bupivacaine Treatment 2a
- Where
- 14 sites in France, Germany and 4 more
- Volunteers
- 115 people
- Sponsor
- Durect
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