Clinical trials: Patient Safety
- Condition Patient Safety
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Primary Immune Deficiency
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy.
- Trial name
- NCT00680446
- Testing
- Immunoglobulin G (Ig NextGen 16%)
- Where
- 9 sites in Australia, New Zealand
- Volunteers
- 41 people
- Sponsor
- CSL Limited
Asthma
Study on BI 54903 (Inhaled Corticosteroid) Administered Once Daily or Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Short Acting Beta-2 Agonist (SABA) Therapy Alone
The aim of this study is to assess and compare efficacy and safety of BI 54903 at doses of very low dose twice daily (b.i.d) and low dose once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic…
- Trial name
- NCT01458886
- Testing
- BI 54903 MD, BI 54903
- Sponsor
- Boehringer Ingelheim
Pulmonary Disease, Chronic Obstructive
Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5.
- Trial name
- NCT00662805
- Testing
- Salmeterol/Fluticasone propionate
- Volunteers
- 762 people
- Sponsor
- GlaxoSmithKline
Hemophilia A
China ADVATE PTP Study
The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in the treatment and prevention of bleeding episodes (BEs)
- Trial name
- NCT02170402
- Testing
- Octocog alfa (recombinant human coagulation factor VIII)
- Where
- 11 sites in China
- Volunteers
- 82 people
- Sponsor
- Baxalta now part of Shire
Locally Advanced Solid Tumor
Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors
This Study is a single arm, open label, multicenter phase III clinical trial to evaluate the safety and efficacy of VC004 in patients with locally advanced/metastatic solid tumors.
- Trial name
- NCT06658353
- Testing
- VC004 Capsules
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Cystinosis
Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)
Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with cystinosis with corneal crystal accumulation observed.
- Trial name
- SCOB2 (NCT04125927)
- Testing
- Mercaptamine
- Where
- 6 sites in Belgium, France and 3 more
- Volunteers
- 5 people
- Sponsor
- RECORDATI GROUP
Hepatolenticular Degeneration; Wilson
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are: Does the device work as expected by removing the excess of…
- Trial name
- MEXWILS (NCT05917327)
- Testing
- Low-volume continuous veno-venous haemodialysis
- Where
- 4 sites in France, Spain
- Volunteers
- 1 people
- Sponsor
- Mexbrain
Primary Sjögren's Syndrome
Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome
This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS) patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if the selected [Zr-89]-rituximab PET/CT method…
- Trial name
- NCT02495129
- Testing
- VAY736 lower dose, VAY736 higher dose
- Sponsor
- Novartis Pharmaceuticals
Refractory Epilepsy, Focal Seizure
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers…
- Conditions
- Refractory Epilepsy, Focal Seizure, Seizures, Focal, Seizures
- Trial name
- NCT04770337
- Testing
- STARSTIM device
- Where
- 32 sites in United States, Belgium and 2 more
- Volunteers
- 127 people
- Sponsor
- Neuroelectrics Corporation
Microtia
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
- Trial name
- AUR-201 (NCT06072040)
- Testing
- AUR-201
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Auregen Biotherapeutics, SA
Intracranial Aneurysm
Safety and Performance of the Neuroform Atlas™ Stent System
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in…
- Trial name
- ATLAS-FR (NCT04162483)
- Testing
- Neuroform Atlas Stent System
- Where
- France
- Volunteers
- 310 people
- Sponsor
- Stryker Neurovascular
Asthma
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- Trial name
- NCT03560466
- Testing
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Where
- 81 sites in United States, Argentina and 16 more
- Volunteers
- 378 people
- Sponsor
- Sanofi
Mucopolysaccharidosis VI
A Study in MPS VI to Assess Safety and Efficacy of Odiparcil
Mucopolysaccharidoses (MPS) are a group of rare inherited disorders characterized by a deficiency of lysosomal enzymes responsible for the normal degradation of glycosaminoglycans (GAGs).
- Trial name
- iMProveS (NCT03370653)
- Testing
- Odiparcil
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 20 people
- Sponsor
- Inventiva Pharma
Hemophilia
Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor
- Trial name
- NCT06922045
- Testing
- STSP-0601 for Injection
- Where
- 18 sites in China
- Volunteers
- 40 people
- Sponsor
- Jiangsu BioJeTay Biotechnology Co., Ltd.
Acute Lymphoblastic Leukemia
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this…
- Trial name
- NCT01471782
- Testing
- Blinatumomab
- Where
- 30 sites in United States, Austria and 5 more
- Volunteers
- 93 people
- Sponsor
- Amgen Research (Munich) GmbH
Biallelic RPE65 Mutation-associated Retinal Dystrophy
Study of Efficacy and Safety of Voretigene Neparvovec in Japanese Patients With Biallelic RPE65 Mutation-associated Retinal Dystrophy
The purpose of this study is to provide safety and efficacy data for voretigene neparvovec, administered as subretinal injection, in Japanese patients with biallelic RPE65 mutation-associated retinal dystrophy.
- Trial name
- NCT04516369
- Testing
- voretigene neparvovec
- Where
- Japan
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Establishing Dose of Sr-hGH in ISS Patients
Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS).
- Trial name
- NCT02042170
- Testing
- human growth hormone self-injection
- Where
- South Korea
- Volunteers
- 46 people
- Sponsor
- LG Life Sciences
Primary Immunodeficiency (PID)
Subcutaneous Ig NextGen 16% in PID Patients
This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP.
- Trial name
- NCT00391131
- Testing
- IgNextGen 16%
- Where
- 12 sites in Australia, New Zealand
- Volunteers
- 35 people
- Sponsor
- CSL Limited
HIV Infections
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment…
- Trial name
- NCT00002419
- Testing
- Abacavir sulfate, Amprenavir, Efavirenz
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Gilead Sciences
Crohn's Disease
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
- Trial name
- VIVID-1 (NCT03926130)
- Testing
- Mirikizumab, Ustekinumab
- Where
- 580 sites in United States, Argentina and 32 more
- Volunteers
- 1,158 people
- Sponsor
- Eli Lilly and Company
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