Clinical trials: Infantile
Hepatitis B
A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the first two years of life and to assess the…
- Trial name
- NCT02798952
- Testing
- Engerix-B Kinder
- Where
- 14 sites in Germany
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infantile Colic, Infantile Functional Gastrointestinal Disorders
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants.
- Trial name
- NCT00655083
- Testing
- Nepadutant
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Menarini Group
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Locally Advanced or Metastatic Infantile Fibrosarcoma Harboring an NTRK Gene Fusion, Infantile Fibrosarcoma
A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database
This is an observational study in which data from the past of children and young people with a specific cancer, called NTRK gene fusion positive infantile fibrosarcoma (IFS) is studied.
- Trial name
- EPI VITRAKVI (NCT05236257)
- Testing
- Larotrectinib (Vitrakvi, BAY2757556), Standard of Care
- Where
- France
- Volunteers
- 93 people
- Sponsor
- Bayer
Hepatitis B
Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three…
- Trial name
- NCT00984139
- Testing
- Engerix™-B Kinder
- Where
- 24 sites in Germany
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infantile Neronal Ceroid Lipofuscinosis
Cystagon to Treat Infantile Neuronal Ceroid Lipofuscinosis
This study will examine the effectiveness of a drug called Cystagon in treating infantile neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children.
- Trial name
- NCT00028262
- Testing
- Cystagon
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Variant Late-Infantile Neuronal Ceroid Lipofuscinosis
Gene Therapy For Children With Variant Late Infantile Neuronal Ceroid Lipofuscinosis 6 (vLINCL6) Disease
This is a phase 1/2, open-label, single dose study to evaluate the safety and efficacy of AT-GTX-501 delivered intrathecally into the lumbar spinal cord region of participants with mild to moderate variant late infantile neuronal…
- Trial name
- NCT02725580
- Testing
- AT-GTX-501
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Emily de los Reyes
Congenital Hyperinsulinism, Hyperinsulinism
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug…
- Conditions
- Congenital Hyperinsulinism, Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy, CHI
- Trial name
- NCT00674440
- Testing
- F-DOPA, PET scan
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Children's Hospital of Philadelphia
Niemann-Pick Disease, Type C
Study of IV VTS-270 for Infantile Liver Disease Associated With Niemann-Pick Disease, Type C
Niemann-Pick disease, type C (NPC) is a lethal, autosomal recessive, lysosomal storage disorder characterized by neurodegeneration in early childhood and death in adolescence.
- Trial name
- NCT03471143
- Testing
- VTS-270
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Washington University School of Medicine
Infantile Colic
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral…
- Trial name
- no-cry (NCT01258153)
- Testing
- Nepadutant oral solution
- Where
- 9 sites in Germany, Poland and 2 more
- Volunteers
- 115 people
- Sponsor
- Menarini Group
Infantile Hemangioma
Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with…
- Trial name
- NCT01056341
- Testing
- Propranolol
- Where
- 59 sites in United States, Australia and 14 more
- Volunteers
- 512 people
- Sponsor
- Pierre Fabre Dermatology
Infantile Neuroaxonal Dystrophy
Desipramine in Infantile Neuroaxonal Dystrophy (INAD).
This is a research study to find out if clinically prescribed desipramine is effective at improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD) in affected children.
- Trial name
- NCT03726996
- Testing
- Desipramine
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Duke University
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets
Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ENPP1 Deficiency
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of INZ-701, an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) enzyme…
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy
- Trial name
- NCT04686175
- Testing
- INZ-701
- Where
- 7 sites in United States, Canada and 3 more
- Volunteers
- 13 people
- Sponsor
- Inozyme Pharma
Infantile Refsum's Disease, Zellweger Syndrome
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II.
- Conditions
- Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders
- Trial name
- NCT00007020
- Testing
- Cholic Acids
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Infantile Spasms
Open-label Extension to Protocol 1042-0500
To allow open-label extension to patients who have completed Protocol 1042-0500
- Trial name
- NCT00442104
- Testing
- Ganaxolone
- Where
- 14 sites in United States
- Volunteers
- 54 people
- Sponsor
- Marinus Pharmaceuticals
Refractory Infantile Spasms
A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients
A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients.
- Trial name
- NCT03976076
- Testing
- JBPOS0101
- Where
- 23 sites in United States, South Korea
- Volunteers
- 16 people
- Sponsor
- Bio-Pharm Solutions Co., Ltd.
Hypophosphatasia (HPP)
Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)
This clinical trial studies the safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP.
- Trial name
- NCT00744042
- Testing
- asfotase alfa
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 11 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Infantile Colic, Colic, Infantile
Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic
This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.
- Trial name
- NCT03434249
- Testing
- Bifidobacterium, BB-12® (Bifidolactis Infant)
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- SOFAR S.p.A.
Infantile Spasm
A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment…
- Trial name
- NCT03421496
- Testing
- Cannabidiol Oral Solution, Vigabatrin
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Hepatitis B
Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy.
- Trial name
- NCT01847430
- Testing
- Engerix™-B Kinder
- Where
- 10 sites in Germany
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline