Clinical trials: Patient Safety
Multiple Sclerosis
Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)
The main aim was to study in the real world setting the effectiveness of Cladribine tablets in terms of Annualized Relapse Rate (ARR) and disability progression, in participants who switched from a first line Disease Modifying…
- Trial name
- NCT04934800
- Testing
- Cladribine
- Where
- 61 sites in Austria, Greece and 5 more
- Volunteers
- 256 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Onychomycosis of Toenail, Onychomycosis
Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail)
A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week will result in mycological cure and/or clear nail growth on the treated hallux toe.
- Trial name
- NCT03216200
- Testing
- plasma treatment
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- DeviceFarm, Inc.
Type 2 Diabetes Mellitus
Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
This is a study to assess the safety and efficacy of the addition of ipragliflozin to sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and…
- Trial name
- NCT02564211
- Testing
- Ipragliflozin, Sitagliptin
- Volunteers
- 77 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Open-Angle Glaucoma, Ocular Hypertension
Dose-Ranging Study of the Bimatoprost Ocular Insert
The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension.
- Trial name
- NCT02358369
- Testing
- Bimatoprost, Timolol 0.5%
- Where
- 10 sites in United States
- Volunteers
- 156 people
- Sponsor
- ForSight Vision5, Inc.
Malaria
MMV390048 POC in Patients With P. Vivax and P. Falciparum Malaria
The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced Blood-Stage Malaria (IBSM) challenge model, and to…
- Trial name
- NCT02880241
- Testing
- MMV390048
- Where
- 2 sites in Ethiopia
- Volunteers
- 8 people
- Sponsor
- Medicines for Malaria Venture
Type 2 Spinal Muscular Atrophy
Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)
This was a Phase III multi-center, single dose (1.2 x 10^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never…
- Trial name
- STEER (NCT05089656)
- Testing
- OAV101
- Where
- 42 sites in United States, Brazil and 11 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Lymphoma
Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma
The goal of this clinical research study is to learn if the combination of the immunotherapy drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug combination will also be studied.
- Trial name
- NCT00904722
- Testing
- CT-011, Rituximab
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- M.D. Anderson Cancer Center
Solid Tumor, Gastric Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
Bipolar Depression
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with…
- Trial name
- NCT01256177
- Testing
- Quetiapine Fumarate (SEROQUEL) Extended Release
- Where
- 12 sites in China
- Volunteers
- 361 people
- Sponsor
- AstraZeneca
Adult Growth Hormone Deficiency
A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency
This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth…
- Trial name
- NCT01247675
- Testing
- ACP-001 (TransCon hGH), Omnitrope
- Where
- 4 sites in Denmark, Germany and 2 more
- Volunteers
- 37 people
- Sponsor
- Ascendis Pharma A/S
Primary Biliary Cirrhosis
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC).
- Trial name
- EPICS (NCT03112681)
- Testing
- Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 9 sites in United States
- Volunteers
- 37 people
- Sponsor
- Zydus Therapeutics Inc.
Chronic Kidney Disease Requiring Chronic Dialysis
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients.
- Trial name
- NCT01324128
- Testing
- PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate, PA21-1 (1.25 g tablet containing 250 mg iron)
- Where
- 15 sites in United States, Austria and 13 more
- Volunteers
- 1,059 people
- Sponsor
- Vifor Pharma
Non-Small Cell Lung Cancer
A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy
This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody) compared with a single agent…
- Trial name
- IPSOS (NCT03191786)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Vinorelbine, Gemcitabine
- Where
- 91 sites in Argentina, Belgium and 22 more
- Volunteers
- 453 people
- Sponsor
- Hoffmann-La Roche
Candidiasis, Invasive, Candidemia
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida…
- Trial name
- CARES (NCT03363841)
- Testing
- SCY-078
- Where
- 12 sites in United States, India and 2 more
- Volunteers
- 30 people
- Sponsor
- Scynexis, Inc.
Hypertension
Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population
The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic…
- Trial name
- ACTION (NCT00760266)
- Testing
- Aliskiren, Hydrochlorothiazide
- Where
- United States
- Volunteers
- 451 people
- Sponsor
- Novartis
COVID-19
Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from…
- Trial name
- APLICOV-PC (NCT04382066)
- Testing
- Plitidepsin 1.5 mg/day, Plitidepsin 2.0 mg/day, Plitidepsin 2.5 mg/day
- Where
- 13 sites in Spain
- Volunteers
- 46 people
- Sponsor
- PharmaMar
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Mantle Cell Lymphoma
A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small…
- Trial name
- NCT02268851
- Testing
- TGR-1202, Ibrutinib
- Where
- 5 sites in United States
- Volunteers
- 45 people
- Sponsor
- Dana-Farber Cancer Institute
Pemphigus Vulgaris, Pemphigus Foliaceus
A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult…
- Trial name
- ADDRESS (NCT04598451)
- Testing
- efgartigimod PH20 SC, prednisone
- Where
- 134 sites in United States, Australia and 19 more
- Volunteers
- 222 people
- Sponsor
- argenx
GNE Myopathy, Hereditary Inclusion Body Myopathy (HIBM)
An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy
The safety objectives of the study are to: evaluate additional long-term safety of SA-ER treatment of participants with GNE myopathy previously treated with SA-ER at dose of 6g/day (Part I); evaluate the safety of 12g /day SA…
- Trial name
- NCT01830972
- Testing
- SA-ER 500 mg, SA-IR 500 mg
- Where
- 4 sites in United States, Israel
- Volunteers
- 59 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Duchenne Muscular Dystrophy
Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy
This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with…
- Trial name
- DYSTANCE 51 (NCT03907072)
- Testing
- WVE-210201 (suvodirsen)
- Where
- 22 sites in United States, Belgium and 6 more
- Volunteers
- 6 people
- Sponsor
- Wave Life Sciences USA, Inc.
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