Clinical trials: Pediatric Disease
Pediatric Gastroenteritis
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals located in four Brazilian regions.
- Trial name
- NCT01195844
- Testing
- Rotavirus Vaccine
- Volunteers
- 230 people
- Sponsor
- Merck Sharp & Dohme LLC
Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children
Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery
This is a prospective, multi-center, single-arm, target-value clinical trial conducted to evaluate the safety and effectiveness of the Thoracic and Abdominal Endoscopic Surgery System (model WJ-SR01-200) in pediatric surgical…
- Conditions
- Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children, Pyeloplasty, Ureteral Reimplantation
- Trial name
- NCT07530133
- Testing
- Thoracic and Abdominal Endoscopic Surgery System
- Where
- 3 sites in China
- Volunteers
- 64 people
- Sponsor
- Hangzhou Kangji Weijing Medical Robotics Co., Ltd.
Allergies
Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine
This is a non-interventional retrospective data collection study from children aged from 2 to 12 years old diagnosed with an allergy and who received a treatment consisting of an H1-antihistamine.
- Trial name
- NCT00453583
- Where
- United States
- Volunteers
- 4,581 people
- Sponsor
- UCB Pharma
Respiratory Syncytial Virus
A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including…
- Trial name
- NCT04528719
- Testing
- mRNA-1345
- Where
- 31 sites in United States
- Volunteers
- 651 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Urinary Bladder, Overactive
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults.
- Trial name
- LION (NCT01565707)
- Testing
- Solifenacin Succinate Suspension, Urotherapy
- Where
- 46 sites in United States, Belgium and 14 more
- Volunteers
- 189 people
- Sponsor
- Astellas Pharma Europe B.V.
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age
A Phase 1/2, Open-label, Multicenter, Non-randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Paediatric Patients from Birth to Less than 1 Year of Age with X-linked Hypophosphatemia…
- Trial name
- NCT04188964
- Testing
- Burosumab
- Where
- 9 sites in Austria, France and 4 more
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
HIV-1
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen…
- Trial name
- NCT00799864
- Testing
- Rilpivirine, Zidovudine, Abacavir
- Where
- 17 sites in United States, India and 6 more
- Volunteers
- 54 people
- Sponsor
- Janssen Sciences Ireland UC
Atopic Dermatitis
Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis
This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants…
- Trial name
- NCT03954158
- Testing
- Crisaborole ointment 2%, Vehicle
- Where
- 3 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Pfizer
Migraine
A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Participants 6 to 17 Years of Age
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM).
- Trial name
- NCT04464707
- Testing
- Fremanezumab
- Where
- 89 sites in United States, Canada and 7 more
- Volunteers
- 292 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
HIV Infections, Chickenpox
A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV
To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.
- Trial name
- NCT00002358
- Testing
- Sorivudine
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
Leukodystrophy, Globoid Cell
Study of Safety, Tolerability and Efficacy of PBKR03 in Pediatric Subjects With Early Infantile Krabbe Disease
PBKR03 is a gene therapy for Krabbe Disease (Globoid cell leukodystrophy) intended to deliver a functional copy of the GALC gene to the brain and peripheral tissues.
- Trial name
- GALax-C (NCT04771416)
- Testing
- PBKR03
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 24 people
- Sponsor
- Gemma Biotherapeutics
Solid Tumors, CNS Tumors
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain…
- Trial name
- STARTRK-NG (NCT02650401)
- Testing
- Entrectinib
- Where
- 26 sites in United States, Canada and 7 more
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
Healthy Subjects
A Study to Explore the Physiological Impact of AIR+ KN95 Masks on Children
The primary objective is to evaluate the physiological impact of AIR+ KN95 Masks on end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age.
- Trial name
- NCT07037381
- Testing
- KN95 mask
- Where
- Singapore
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Innosparks Pte Ltd.
Mucopolysaccharidosis II
Mucopolysaccharidosis Type II Observational
This is an observational study planned to document prospectively disease manifestation and neurocognitive course in pediatric patients with a clinical presentation consistent with neuronopathic ("severe") MPS II undergoing…
- Trial name
- NCT04591834
- Testing
- Observational
- Where
- 3 sites in United States, Canada
- Sponsor
- REGENXBIO Inc.
Acute Myeloid Leukemia
A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment.
- Trial name
- NCT07306832
- Testing
- Pivekimab Sunirine
- Where
- 14 sites in United States, Australia and 5 more
- Volunteers
- 18 people
- Sponsor
- AbbVie
Spinal Muscular Atrophy
Real-World Use of Novel Treatments in Patients With Spinal Muscular Atrophy (SMA): A Multi-Site Retrospective Chart Review of Pediatric SMA Patients Outside of the United States
This global, retrospective, non-interventional, medical chart review (MCR), descriptive study collected patient-level data in regions outside the US.
- Trial name
- NCT06178393
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Congenital Hypothyroidism
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH.
- Trial name
- NCT05228184
- Testing
- Tirosint®-SOL, Levothyroxine Sodium
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- IBSA Institut Biochimique SA
Ulcerative Colitis, Crohn's Disease
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time.
- Trial name
- NCT06405087
- Testing
- Vedolizumab SC, No Intervention
- Where
- 47 sites in United States, Belgium and 12 more
- Volunteers
- 70 people
- Sponsor
- Takeda
Hodgkin Lymphoma, Adult, Hodgkin Disease Recurrent
Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)
This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.
- Conditions
- Hodgkin Lymphoma, Adult, Hodgkin Disease Recurrent, Hodgkin Disease Refractory, Hodgkin Disease, Pediatric
- Trial name
- NCT04268706
- Testing
- CD30.CAR-T, Fludarabine, Bendamustine
- Where
- 5 sites in United States
- Volunteers
- 97 people
- Sponsor
- Tessa Therapeutics
Hunter Syndrome
Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094
This extension study will allow participants that completed Study HGT-HIT-094 to continue receiving Elaprase treatment in conjunction with idursulfase IT or to continue receiving Elaprase treatment and begin concurrent IT…
- Trial name
- NCT02412787
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 56 people
- Sponsor
- Shire
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