Clinical trials: Patient Safety
Immune Thrombocytopenic Purpura (ITP)
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic…
- Trial name
- NCT03866577
- Testing
- Biological: M254, Intravenous immunoglobulin (IVIg)
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Momenta Pharmaceuticals, Inc.
Hematologic Neoplasms, Hemorrhage
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet transfusions.
- Conditions
- Hematologic Neoplasms, Hemorrhage, Hematopoietic Stem Cell Transplantation
- Trial name
- TREATT (NCT03136445)
- Testing
- Tranexamic acid (TXA).
- Where
- 27 sites in Australia, United Kingdom
- Volunteers
- 616 people
- Sponsor
- NHS Blood and Transplant
Alopecia Areata
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
- Trial name
- THRIVE-AA1 (NCT04518995)
- Testing
- CTP-543
- Where
- 72 sites in United States, Canada and 3 more
- Volunteers
- 706 people
- Sponsor
- Concert Pharmaceuticals
Age - Related Macular Degeneration (AMD)
Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to…
- Trial name
- RE-VIEW (NCT01722045)
- Testing
- Intravitreal Aflibercept Injection (IAI)
- Where
- 49 sites in United States
- Volunteers
- 154 people
- Sponsor
- Regeneron Pharmaceuticals
Ligneous Conjunctivitis
Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients
Kedrion Human Plasminogen, a sterile human plasma-derived plasminogen preparation for topical ocular use will be evaluated for the indication of treatment of ligneous conjunctivitis.
- Trial name
- NCT01554956
- Testing
- Human Plasminogen
- Where
- 3 sites in United States, Italy
- Volunteers
- 12 people
- Sponsor
- Kedrion S.p.A.
Colorectal Cancer
A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer
The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer.
- Trial name
- NCT05619172
- Testing
- Nanrilkefusp alfa, Cetuximab
- Where
- 8 sites in Belgium, France and 1 more
- Volunteers
- 16 people
- Sponsor
- SOTIO Biotech AG
Cystic Fibrosis
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler
- Trial name
- EAGER (NCT00388505)
- Testing
- Tobramycin Inhalation Powder, Tobramycin Solution for Inhalation
- Where
- 72 sites in United States, Australia and 12 more
- Volunteers
- 517 people
- Sponsor
- Novartis Pharmaceuticals
Neurotrophic Keratitis, Keratitis
Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis.
This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent…
- Conditions
- Neurotrophic Keratitis, Keratitis, Corneal Ulcer
- Trial name
- REPARO (NCT01756456)
- Testing
- rhNGF 10 μg/ml, rhNGF 20 μg/ml, vehicle
- Where
- 34 sites in France, Germany and 4 more
- Volunteers
- 174 people
- Sponsor
- Dompé Farmaceutici S.p.A
Macular Edema
Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision…
- Trial name
- NCT02732951
- Testing
- BI 1026706
- Where
- 35 sites in Belgium, France and 6 more
- Volunteers
- 105 people
- Sponsor
- Boehringer Ingelheim
Epilepsy, Generalized Tonic-clonic Seizures
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic…
- Trial name
- NCT01292837
- Testing
- Levetiracetam
- Where
- 26 sites in Japan
- Volunteers
- 13 people
- Sponsor
- UCB Japan Co. Ltd.
Cushings Disease, Cushing Disease
Safety and Efficacy of LCI699 in Cushing's Disease Patients
This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease.
- Trial name
- NCT01331239
- Testing
- LCI699
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Pancreatic Ductal Adenocarcinoma
Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma
This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine and nab-paclitaxel with an oral hedgehog inhibitor LDE225 (Sonidegib).
- Trial name
- NCT01431794
- Testing
- LDE225-600mg, Gemcitabine, nab-paclitaxel
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Amyotrophic Lateral Sclerosis (ALS)
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients
This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are…
- Trial name
- NCT03280056
- Testing
- NurOwn® (MSC-NTF cells), Bone Marrow aspiration
- Where
- 6 sites in United States
- Volunteers
- 196 people
- Sponsor
- Brainstorm-Cell Therapeutics
Geographic Atrophy
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy…
- Trial name
- SPECTRI (NCT02247531)
- Testing
- Lampalizumab
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 975 people
- Sponsor
- Hoffmann-La Roche
Cushing's Syndrome
Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699
The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators'…
- Trial name
- NCT03606408
- Testing
- osilodrostat
- Where
- 56 sites in United States, Argentina and 19 more
- Volunteers
- 127 people
- Sponsor
- RECORDATI GROUP
Bipolar Depression
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major…
- Trial name
- NCT03249376
- Testing
- Lumateperone
- Where
- 47 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Congenital Adrenal Hyperplasia
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
This study is a parallel arm, randomised, open-label study, including dose titration and admissions for four overnight stays for 24-hour endocrine profiles.
- Trial name
- NCT02716818
- Testing
- Chronocort®, standard glucocorticoid therapy
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Neurocrine UK Limited
Multiple Myeloma
Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma
The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for multiple myeloma to a regimen of bendamustine and prednisolone.
- Trial name
- NCT01179490
- Testing
- SyB L-0501, prednisolone
- Where
- 3 sites in Japan
- Volunteers
- 5 people
- Sponsor
- SymBio Pharmaceuticals
Relapsed and/or Refractory Multiple Myeloma (RRMM)
A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)
TAK-981 is being tested in combination with anti-CD38 monoclonal antibodies (mAbs) to treat participants who have relapsed or refractory multiple myeloma (RRMM).
- Trial name
- NCT04776018
- Testing
- TAK-981, Mezagitamab, Daratumumab and Hyaluronidase-fihj
- Where
- 13 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Takeda
Myelodysplastic Syndrome
Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)
The purpose of this study is to investigate tolerability when SyB L-1101 is administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and…
- Trial name
- NCT01700335
- Testing
- SyB L-1101
- Where
- 3 sites in Japan
- Volunteers
- 9 people
- Sponsor
- SymBio Pharmaceuticals
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