Clinical trials: Pediatric Patients
Hypertension, Pulmonary
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months.
- Trial name
- NCT01342952
- Testing
- Ambrisentan
- Where
- 22 sites in United States, Argentina and 7 more
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Anemia, Chronic Kidney Disease
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is…
- Conditions
- Anemia, Chronic Kidney Disease, Kidney Disease
- Trial name
- NCT00436748
- Testing
- Darbepoetin Alfa
- Where
- 67 sites in United States, Belgium and 8 more
- Volunteers
- 116 people
- Sponsor
- Amgen
Purpura, Thrombocytopenic, Idiopathic
A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
This was an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450.
- Trial name
- NCT02201290
- Testing
- Eltrombopag Tablets, Eltrombopag PfOS
- Where
- 3 sites in Russia
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Hypovolemia
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major…
- Trial name
- NCT01531803
- Testing
- Kedbumin 25%, Normal Saline Solution
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kedrion S.p.A.
Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1)
MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901).
- Trial name
- ReNeu (NCT03962543)
- Testing
- Mirdametinib (PD-0325901) oral capsule or dispersible tablet
- Where
- 43 sites in United States
- Volunteers
- 114 people
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Ankle Sprain
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).
- Trial name
- NCT01037816
- Testing
- FS-67 Patch
- Where
- 23 sites in United States
- Volunteers
- 252 people
- Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
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
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
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
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
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
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
Asthma
Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma
This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period.
- Trial name
- NCT02113436
- Testing
- FP/ SLM HFA MDI 50/25 mcg, FP HFA MDI 50 mcg
- Where
- 69 sites in Japan
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Short Bowel Syndrome
A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
The main aims of the study are to check for side effects from teduglutide. Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks.
- Trial name
- NCT05027308
- Testing
- Teduglutide
- Where
- 6 sites in Japan
- Volunteers
- 3 people
- Sponsor
- Takeda
Metabolic Disorders
A Trial of a Single ProHema-CB Product Transplant in Pediatric Patients With Inherited Metabolic Disorders
The purpose of this study is to describe the safety profile of ProHema-CB as part of a single cord blood unit transplant after a myeloablative conditioning regimen in pediatric patients with inherited metabolic disorders.
- Trial name
- PROVIDE (NCT02354443)
- Testing
- ProHema-CB Transplant
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Fate Therapeutics
Restless Legs Syndrome
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Autistic Disorder, Autism
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder…
- Conditions
- Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome
- Trial name
- NCT01592747
- Testing
- Memantine Hydrochloride (HCl)
- Where
- 94 sites in United States, Belgium and 13 more
- Volunteers
- 479 people
- Sponsor
- Forest Laboratories
Constipation
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.
- Trial name
- NCT00452335
- Testing
- Lubiprostone
- Where
- 19 sites in United States
- Volunteers
- 127 people
- Sponsor
- Sucampo Pharma Americas, LLC