Clinical trials: Standard Care Control
- Condition Standard Care Control
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
Laceration of Skin
Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department
A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair.
- Trial name
- ZIPPED (NCT04122859)
- Testing
- Zip Skin Closure Device
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- ZipLine Medical Inc.
Dravet Syndrome
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet…
- Trial name
- NCT02926898
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 87 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Respiratory Syncytial Virus Infection
A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171
The primary objective of the study is to investigate the safety and tolerability of ALX-0171. The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic…
- Trial name
- NCT02309320
- Testing
- ALX-0171
- Where
- 59 sites in Australia, Belgium and 12 more
- Volunteers
- 53 people
- Sponsor
- Ablynx, a Sanofi company
Asthma
Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016)…
- Trial name
- NCT02555683
- Testing
- QAW039
- Where
- 234 sites in United States, Argentina and 25 more
- Volunteers
- 894 people
- Sponsor
- Novartis Pharmaceuticals
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORE (NCT07188805)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 133 sites in United States, Argentina and 21 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Injury, Spinal Cord
Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care
This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates…
- Trial name
- INSPIRE 2 (NCT03762655)
- Testing
- Neuro-Spinal Scaffold
- Where
- 16 sites in United States
- Volunteers
- 20 people
- Sponsor
- InVivo Therapeutics
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Asthma
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the…
- Trial name
- NCT02563067
- Testing
- QAW039
- Where
- 163 sites in United States, Argentina and 17 more
- Volunteers
- 877 people
- Sponsor
- Novartis Pharmaceuticals
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S.
- Trial name
- DISRUPT (NCT04160468)
- Testing
- Exebacase
- Where
- 55 sites in United States
- Volunteers
- 259 people
- Sponsor
- ContraFect
Systemic Lupus Erythematosus
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
- Trial name
- BLOSSOM (NCT05835310)
- Testing
- Anifrolumab
- Where
- 103 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Lung Diseases, Interstitial
A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).
- Trial name
- InPedILD® (NCT04093024)
- Testing
- Nintedanib
- Where
- 43 sites in United States, Argentina and 19 more
- Volunteers
- 39 people
- Sponsor
- Boehringer Ingelheim
Influenza A
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
- Trial name
- NCT03381196
- Testing
- Pimodivir 600 mg, SOC Treatment
- Where
- 427 sites in United States, Argentina and 36 more
- Volunteers
- 553 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV)…
- Conditions
- Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection, Respiratory Syncytial Viral (RSV) Infection
- Trial name
- NCT04933968
- Testing
- ALVR106
- Where
- 21 sites in United States
- Volunteers
- 17 people
- Sponsor
- AlloVir
MPS-IH (Hurler Syndrome)
A Study to Investigate the Efficacy and Safety of OTL-203 in Subjects With MPS-IH Compared With Standard of Care With Allogeneic HSCT
A multi-center randomized clinical trial to compare OTL-203 (gene therapy) with stem cell transplant (standard of care) in patients with MPS-IH (Hurler syndrome).
- Trial name
- HURCULES (NCT06149403)
- Testing
- Experimental: OTL-203, Active Comparator: Allo-HSCT
- Where
- 5 sites in United States, Italy and 2 more
- Volunteers
- 41 people
- Sponsor
- Orchard Therapeutics
Anemia
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
- Trial name
- NCT00548860
- Testing
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Where
- United States
- Volunteers
- 2,018 people
- Sponsor
- American Regent, Inc.
Asthma
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when…
- Trial name
- NCT03052517
- Testing
- QAW039 150 mg, QAW039 450 mg
- Where
- 347 sites in United States, Argentina and 40 more
- Volunteers
- 2,538 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants…
- Trial name
- SIRIUS-SLE 1 (NCT05639114)
- Testing
- Ianalumab
- Where
- 135 sites in United States, Argentina and 17 more
- Volunteers
- 436 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis
Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis
Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other…
- Trial name
- NCT00616538
- Testing
- Epiceram(r), Fluticasone Propionate 0.05%
- Volunteers
- 121 people
- Sponsor
- Ceragenix Pharmaceuticals
Amblyopia
CURESIGHT BINOCULAR AMBLYOPIA TREATMENT STUDY
Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the…
- Trial name
- NCT04785690
- Testing
- CureSight, Patching
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- NovaSight