Clinical trials: Pediatric Safety and Effectiveness
Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric…
- Trial name
- VOCAL-EXT (NCT05962788)
- Testing
- voclosporin
- Where
- 6 sites in United States, Colombia and 3 more
- Volunteers
- 4 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Chronic Pain, Postsurgical Pain
Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children
The purpose of this study was to assess the safety and pharmacokinetics (single- and multiple-dose) of oxymorphone ER for the relief of moderate to severe pain in pediatric participants ages 7 - ≤17 years old requiring a…
- Trial name
- NCT04681027
- Testing
- Oxymorphone hydrochloride (HCl)
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Progressive Keratoconus
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the…
- Trial name
- CXL (NCT00925327)
- Testing
- Corneal collagen cross-linking with riboflavin/UVA light
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Peschke Meditrade, GmbH
Seizures
Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures
The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.
- Trial name
- NCT02897856
- Testing
- Buccal midazolam, Intramuscular midazolam
- Where
- Qatar
- Volunteers
- 150 people
- Sponsor
- Hamad Medical Corporation
Immune Thrombocytopenia, Treatment
Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)
To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one…
- Trial name
- NCT06168851
- Testing
- Anti-CD38 antibody Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Atopic Dermatitis
Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e.
- Trial name
- NCT00925730
- Testing
- Pimecrolimus
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Novartis
Pain
Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.
- Trial name
- NCT01982539
- Testing
- Zipsor®
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Depomed
Allergic Asthma
Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
The primary purpose of this study is to examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/mL (target level).
- Trial name
- NCT01155700
- Testing
- omalizumab
- Where
- 17 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
Pediatric Cancer
Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
The purpose is to evaluate the effectiveness and safety of fosaprepitant plus ondansetron with dexamethasone or placebo plus ondansetron with dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HE…
- Trial name
- NCT04508400
- Testing
- Fosaprepitant,ondansetron, dexamethasone
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Sun Yat-sen University
Ventricular Septal Defect, Atrioventricular Septal Defect
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects.
- Conditions
- Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
- Trial name
- NCT05253209
- Testing
- L-citrulline, Plasmalyte A
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Epilepsy With Partial-onset Seizures
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications.
- Trial name
- NCT02477839
- Testing
- Lacosamide
- Where
- 88 sites in United States, Argentina and 24 more
- Volunteers
- 255 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period
ACTIVATE-KidsT (AG348-C-022) is a multicenter study designed to evaluate the efficacy and safety of treatment with mitapivat compared with placebo in pediatric participants with pyruvate kinase deficiency (PK deficiency) who are…
- Trial name
- ACTIVATE-KidsT (NCT05144256)
- Testing
- Mitapivat
- Where
- 22 sites in United States, Canada and 8 more
- Volunteers
- 49 people
- Sponsor
- Agios Pharmaceuticals, Inc.
Idiopathic Thrombocytopenic Purpura
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study.
- Trial name
- PETIT2 (NCT01520909)
- Testing
- Eltrombopag
- Where
- 51 sites in United States, Argentina and 11 more
- Volunteers
- 92 people
- Sponsor
- GlaxoSmithKline
Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
A Study of OV101 in Individuals With Angelman Syndrome (AS)
The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.
- Trial name
- NEPTUNE (NCT04106557)
- Testing
- Gaboxadol
- Where
- 14 sites in United States, Australia and 3 more
- Volunteers
- 104 people
- Sponsor
- Ovid Therapeutics Inc.
Urea Cycle Disorder
UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder
UNLOCKED: A Phase 2 Trial to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care
- Trial name
- UNLOCKED (NCT03933410)
- Testing
- KB195
- Where
- 19 sites in United States, Belgium and 5 more
- Volunteers
- 13 people
- Sponsor
- Kaleido Biosciences
Common Cold, Influenza
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.
The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old…
- Trial name
- ACCORD (NCT02644018)
- Testing
- Imidazolyl ethanamide pentandioic acid
- Where
- 13 sites in Russia
- Volunteers
- 190 people
- Sponsor
- Valenta Pharm JSC
AML, Childhood, Relapse/Recurrence
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.
- Conditions
- AML, Childhood, Relapse/Recurrence, Refractory AML, Core Binding Factor Acute Myeloid Leukemia
- Trial name
- NCT06316960
- Testing
- Avapritinib, Azacitidine Injection, Decitabine Injection
- Where
- 12 sites in China
- Volunteers
- 50 people
- Sponsor
- Children's Hospital of Soochow University
Hypophosphatasia
Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease
The study will evaluate safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 2 different doses (approved dose and lower dose) of asfotase alfa in adult participants with pediatric-onset hypophosphatasia (HPP).
- Trial name
- REBUILD (NCT04189315)
- Testing
- asfotase alfa
- Sponsor
- Alexion Pharmaceuticals, Inc.
High-Grade Glioma (HGG), Posterior Fossa-A Ependymoma
A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma
This study is researching an experimental drug called cemiplimab (called "study drug") and the combination of experimental drugs of fianlimab and cemiplimab (called "study drugs").
- Trial name
- NCT07567469
- Testing
- Cemiplimab, Cemiplimab+Fianlimab Fixed Dose Combination (FDC)
- Volunteers
- 120 people
- Sponsor
- Regeneron Pharmaceuticals
Molybdenum Cofactor Deficiency, Type A
Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP
This study will include a screening period, a 6-month treatment period, followed by long-term extension period expected to last approximately 72 months.
- Trial name
- NCT02047461
- Testing
- ORGN001 (formerly ALXN1101)
- Where
- 6 sites in United States, Australia and 3 more
- Volunteers
- 8 people
- Sponsor
- Origin Biosciences
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