Clinical trials: Pediatric Patients
Primary Hemophagocytic Lymphohistiocytosis
Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis
The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab (previously known as NI-0501) as a treatment for primary haemophagocytic lymphohistiocytosis (HLH) patients, including on long-term…
- Trial name
- NCT03312751
- Testing
- Emapalumab
- Where
- 27 sites in United States, Canada and 6 more
- Volunteers
- 35 people
- Sponsor
- Swedish Orphan Biovitrum
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS patients that completed the CACZ885D2307 study
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT01576367
- Testing
- ACZ885
- Where
- 12 sites in Belgium, Canada and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Pediatric Acute Myeloid Leukemia
Home Away From Home - Quality of Life Surveys
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications.
- Trial name
- Aim 3 (NCT02777021)
- Where
- 15 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Stage II Childhood Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma
Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma
This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma.
- Conditions
- Stage II Childhood Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma, Stage IV Childhood Hodgkin Lymphoma
- Trial name
- NCT01920932
- Testing
- brentuximab vedotin, etoposide, prednisone
- Where
- 6 sites in United States
- Volunteers
- 77 people
- Sponsor
- St. Jude Children's Research Hospital
Herpes Simplex
Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients
The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety of valaciclovir (VACV) in the adult and pediatric HSCT patients.
- Trial name
- NCT01602562
- Testing
- VACV tablets (Adults or pediatrics) or granules (pediatrics)
- Where
- 11 sites in Japan
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Methemoglobinemia
Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics
To establish and compare maximum methemoglobin blood levels and times to maximum methemoglobin blood levels following the administration of the injectable local anesthetics prilocaine and lidocaine when used for dental treatment…
- Trial name
- NCT01402869
- Testing
- 4% prilocaine plain, 2% Lidocaine with 1:100,000 epinephrine
- Where
- United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Loma Linda University
Influenza, Human
Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital
The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection.
- Trial name
- NCT01014988
- Testing
- zanamivir aqueous solution
- Where
- 110 sites in United States, Australia and 11 more
- Volunteers
- 202 people
- Sponsor
- GlaxoSmithKline
Acute Heart Failure
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)
- Trial name
- RELAX-PEDS-PK (NCT02151383)
- Testing
- Serelaxin
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Malnutrition, Child
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at…
- Trial name
- NCT03563222
- Testing
- Smoflipid, Intralipid, 20%
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fresenius Kabi
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
Advanced Malignant Solid Neoplasm, Recurrent Ependymal Tumor
Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well ulixertinib works in treating patients with solid tumors that have spread to other places in the body (advanced), non-Hodgkin lymphoma, or histiocytic disorders that have a…
- Conditions
- Advanced Malignant Solid Neoplasm, Recurrent Ependymal Tumor, Recurrent Ewing Sarcoma, Recurrent Glioma
- Trial name
- NCT03698994
- Testing
- Pharmacokinetic Study, Ulixertinib
- Where
- 107 sites in United States, Puerto Rico
- Volunteers
- 20 people
- Sponsor
- National Cancer Institute (NCI)
Pediatric Safety and Effectiveness
Vfend Special Investigation For Pediatric - Observational
Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.
- Trial name
- NCT02554656
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Pfizer
Idiopathic Thrombocytopenic Purpura, Thrombocytopenia
Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients
The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured by durable platelet response.
- Conditions
- Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- Trial name
- NCT01444417
- Testing
- Romiplostim
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 62 people
- Sponsor
- Amgen
Migraine
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17.
- Trial name
- PIONEER-PEDS2 (NCT04396574)
- Testing
- Lasmiditan
- Where
- 134 sites in United States, Belgium and 13 more
- Volunteers
- 558 people
- Sponsor
- Eli Lilly and Company
Sickle Cell Anemia
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult patients with sickle cell anemia (SCA).
- Trial name
- NCT02961218
- Testing
- ACZ885
- Where
- 15 sites in United States, Canada and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Central Nervous System Diseases
Safety and Efficacy of MultiHance in Pediatric Patients
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
- Trial name
- NCT00323310
- Testing
- gadobenate dimeglumine
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Bracco Diagnostics, Inc
Acne Vulgaris
An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris
This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve hours for two weeks, in pediatric patients 9…
- Trial name
- NCT02720627
- Testing
- cortexolone 17α-propionate
- Where
- 10 sites in United States, Poland
- Volunteers
- 27 people
- Sponsor
- Cassiopea SpA
Granulomatosis With Polyangiitis
A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA)…
- Trial name
- NCT01750697
- Testing
- Rituximab
- Where
- 23 sites in United States, Canada and 6 more
- Volunteers
- 25 people
- Sponsor
- Hoffmann-La Roche
CTX
Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)
The study is made up of two cohorts: a randomized double-blind crossover (placebo withdrawal with rescue) study among patients ≥ 16 years of age (adult cohort) and an open-label dose titration study among pediatric patients ≥1…
- Trial name
- NCT04270682
- Testing
- Blinded CDCA 250 mg TID, Open-Label CDCA 250 mg TID, Rescue Medication CDCA 250 mg TID
- Where
- 12 sites in United States, Brazil
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.