Clinical trials: Pediatric Patients
Pain
A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain
This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate in pediatric subjects with mild to moderate post-procedural pain.
- Trial name
- NCT01676493
- Testing
- Codeine
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Roxane Laboratories
Acute Lymphoblastic Leukemia
CD19- and CD22-directed CAR-T Cell Therapy in Patients With Acute Lymphoblastic Leukemia
This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous chimeric antigen receptor (CAR) T cells targeting both CD19 and CD22, manufactured with T-Charge(TM) process.
- Trial name
- NCT05168748
- Testing
- IMJ995 single agent
- Sponsor
- Novartis Pharmaceuticals
Pediatric Malignant Solid Tumor and Epithelioid Sarcoma
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
This is a multicenter, open-label, uncontrolled Phase I/II study to evaluate the efficacy, safety, and pharmacokinetics of ONO-4538HSC in pediatric patients with malignant solid tumors and in patients with epithelioid sarcoma…
- Trial name
- NCT07734116
- Testing
- ONO-4538HSC
- Where
- 15 sites in Japan
- Volunteers
- 50 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Chronic Pain
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic…
- Trial name
- NCT02321319
- Testing
- Hydromorphone HCl ER Tablets
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Mallinckrodt
Pediatric Glaucoma, Elevated IOP in Pediatric Patients
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma…
- Conditions
- Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
- Trial name
- NCT01652664
- Testing
- Travoprost 0.004% PQ ophthalmic solution, Timolol, 0.5% or 0.25% ophthalmic solution, Travoprost Vehicle
- Volunteers
- 184 people
- Sponsor
- Alcon Research
Kawasaki Disease
Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease
The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
- Trial name
- NCT01524939
- Testing
- immunoglobulin G
- Where
- 7 sites in South Korea
- Volunteers
- 45 people
- Sponsor
- Green Cross Corporation
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
Juvenile Idiopathic Arthritis
Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than 18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).
- Trial name
- NCT01513902
- Testing
- CP-690,550
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 26 people
- Sponsor
- Pfizer
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia
A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Relapsed Leukemia
- Trial name
- NCT00315705
- Testing
- clofarabine, Etoposide, Cyclophosphamide
- Where
- 13 sites in United States
- Volunteers
- 50 people
- Sponsor
- Genzyme, a Sanofi Company
Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease
A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the…
- Trial name
- NCT07564505
- Testing
- Adalimumab Solution for Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Stargardt Disease Type 1 (STGD1)
An Clinical Study Evaluating the Safety, Tolerability, and efficAcy of HG005 in StaRgardT Disease
Stargardt disease type 1 (STGD1) is a rare genetic eye condition that causes progressive vision loss, often beginning in childhood or adolescence.
- Trial name
- START (NCT07063251)
- Testing
- HG005
- Where
- China
- Volunteers
- 6 people
- Sponsor
- HuidaGene Therapeutics Co., Ltd.
Neuroblastoma, Rhabdomyosarcoma
Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors
The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24…
- Conditions
- Neuroblastoma, Rhabdomyosarcoma, Ewing's Sarcoma, Ewing's Tumor
- Trial name
- NCT01962103
- Testing
- nab-paclitaxel
- Where
- 20 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Celgene
Glaucoma, Ocular Hypertension
A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.
To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.
- Trial name
- NCT00638742
- Testing
- latanoprost
- Where
- 13 sites in United States, Denmark and 4 more
- Volunteers
- 47 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Solid Tumor, Lymphoma
A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of surufatinib, thereby identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of surufatinib administered in combination with…
- Conditions
- Solid Tumor, Lymphoma, Osteosarcoma, Ewing Sarcoma
- Trial name
- NCT05093322
- Testing
- Surufatinib in combination with Gemcitabine
- Where
- 11 sites in United States
- Volunteers
- 13 people
- Sponsor
- Hutchmed
Chronic Constipation
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation.
- Trial name
- NCT02961556
- Testing
- AJG555
- Where
- 11 sites in Japan
- Volunteers
- 39 people
- Sponsor
- EA Pharma Co., Ltd.
Hemophilia B
BAX 326 Pediatric Study
The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life in pediatric patients.
- Trial name
- NCT01488994
- Testing
- BAX326
- Where
- 11 sites in India, Poland and 4 more
- Volunteers
- 23 people
- Sponsor
- Baxalta now part of Shire
Duchenne Muscular Dystrophy
Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD)
The main objective of this study is to evaluate the efficacy of SRP-4045 (casimersen) and SRP-4053 (golodirsen) compared to placebo in participants with DMD with out-of-frame deletion mutations amenable to skipping exon 45 and…
- Trial name
- ESSENCE (NCT02500381)
- Testing
- SRP-4045, SRP-4053
- Where
- 76 sites in United States, Argentina and 22 more
- Volunteers
- 228 people
- Sponsor
- Sarepta Therapeutics, Inc.
Leukemia, Lymphoma
BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma.
- Trial name
- NCT00077493
- Testing
- BL22 immunotoxin, antibody-drug conjugate therapy, immunotoxin therapy
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- MedImmune LLC
Asthma
Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well…
- Trial name
- NCT01346852
- Testing
- Asthma treatment with an asthma-related medication and at least one asthma controller medication
- Volunteers
- 101,437 people
- Sponsor
- GlaxoSmithKline
PIK3CA-related Overgrowth Spectrum (PROS)
Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
This Phase II, multicenter, open-label study, preceded by a retrospective non-interventional period, is assessing the long-term safety and efficacy of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth…
- Trial name
- EPIK-P3 (NCT04980833)
- Testing
- Alpelisib
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals