Clinical trials: Pediatric Patients
Venous Thromboembolism
A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
- Trial name
- NCT05966740
- Where
- 10 sites in United States
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim
Hemorrhage
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.
- Trial name
- NCT01192022
- Testing
- TachoSil®, Surgicel® Original
- Where
- 17 sites in United States
- Volunteers
- 253 people
- Sponsor
- Takeda
Methylmalonic Acidemia
Gene Therapy With hLB-001 in Pediatric Patients With Severe Methylmalonic Acidemia
The SUNRISE trial is a first-in-human (FIH), open-label, Phase 1/2 clinical trial designed to assess the safety, tolerability and preliminary efficacy of a single intravenous infusion of hLB-001 in pediatric patients with MMA…
- Trial name
- SUNRISE (NCT04581785)
- Testing
- hLB-001
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- LogicBio Therapeutics, Inc
Asthma
Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma
This clinical study was designed to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed…
- Trial name
- NCT04589663
- Testing
- Mometasone furoate, QMF149, Standard of Care (Soc)
- Where
- 3 sites in Hungary, South Africa
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Glycogen Storage Disease Type II-Pompe's Disease
A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
This is a multi-stage, phase 2, open-label, multicenter, multinational, ascending dose cohort, repeated intravenous (IV) infusion study of avalglucosidase alfa in pediatric patients with Infantile-Onset Pompe Disease (IOPD) who…
- Trial name
- Mini-COMET (NCT03019406)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Childhood Absence Epilepsy
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03355300
- Testing
- Cannabidiol Oral Solution
- Where
- 9 sites in United States
- Volunteers
- 11 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Growth and Development
Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus
The primary objective of CRAD001M2305 was to report the long-term effects of everolimus treatment on height, weight and sexual development (using Tanner Stages) in children and adolescents with Tuberous Sclerosis Complex…
- Trial name
- EXIST-LT (NCT02338609)
- Testing
- Everolimus
- Where
- 6 sites in United States, Belgium and 1 more
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Pain Management, Spinal Fusion
Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine).
- Conditions
- Pain Management, Spinal Fusion, Scoliosis
- Trial name
- NCT00880607
- Testing
- Intrathecal morphine, Extended Release Epidural Morphine
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Colorado, Denver
Type 1 Diabetes
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years.
- Trial name
- RescuiNGkids (NCT04992312)
- Testing
- Glucagon Nasal Powder [Baqsimi]
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Eli Lilly and Company
Hypothyroidism, Trisomy 21
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Children with levothyroxine (T21) have developmental delay and other functional gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption.
- Trial name
- NCT04747275
- Testing
- Liquid stable levothyroxine (L-T4) Tirosint-SOL, Oral tablet levothyroxine (L-T4)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Children's Mercy Hospital Kansas City
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
- Trial name
- NCT03255226
- Testing
- Tolvaptan
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Sleep Apnea, Obstructive
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored polysomnography and in-laboratory…
- Trial name
- NCT03473548
- Testing
- Portable sleep monitor, In-laboratory Polysomnography
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Pediatric Crohn's Disease
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea.
- Trial name
- NCT02578238
- Volunteers
- 143 people
- Sponsor
- AbbVie
Mixed Lineage Acute Leukemia, Acute Myeloid Leukemia
Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies
This study will test the safety and effectiveness of adding bortezomib and vorinostat to other chemotherapy drugs commonly used to treat relapsed or refractory leukemia.
- Conditions
- Mixed Lineage Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoid Leukemia
- Trial name
- NCT02419755
- Testing
- Bortezomib, Vorinostat, Mitoxantrone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- St. Jude Children's Research Hospital
Autism, Aggression
The Family VOICE Study
Family centered mental health treatment with children values and supports the role of parents in their child's recovery. However, medications are often the primary focus in community treatment, even in preschool age youth, with…
- Conditions
- Autism, Aggression, Bipolar Disorder, Psychotic Disorders
- Trial name
- NCT01804582
- Testing
- Family Navigator consultation
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- University of Maryland, Baltimore
Non-Hodgkin Lymphoma
Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients
The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and…
- Trial name
- BIANCA (NCT03610724)
- Testing
- Tisagenlecleucel, lymphodepleting chemotherapy, Bridging Therapy
- Where
- 26 sites in United States, Australia and 12 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Anxiety, Pain
An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)
The goal of this randomized trial is to examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) in reducing anxiety and improving the recovery process in children undergoing surgery.
- Conditions
- Anxiety, Pain, Postoperative Behavior
- Trial name
- WebTIPS (NCT03730259)
- Testing
- Web-based Tailored Intervention Preparation for Surgery
- Where
- 2 sites in United States
- Volunteers
- 1,274 people
- Sponsor
- University of California, Irvine
Sickle Cell Disease (SCD)
Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients
The purpose of this study was to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 2 to <18 years with a history of Vaso-Occlusive Crisis (VOC) with or without…
- Trial name
- NCT03474965
- Testing
- Crizanlizumab
- Where
- 35 sites in United States, Belgium and 12 more
- Volunteers
- 117 people
- Sponsor
- Novartis Pharmaceuticals
HIV
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients…
- Trial name
- PRINCE2 (NCT01335698)
- Testing
- Atazanavir Sulphate, Ritonavir
- Where
- 32 sites in United States, Argentina and 9 more
- Volunteers
- 160 people
- Sponsor
- Bristol-Myers Squibb
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00981214
- Testing
- EUR-1008 (APT-1008)
- Where
- 14 sites in United States
- Volunteers
- 19 people
- Sponsor
- Forest Laboratories