Clinical trials: Hyperbilirubinemia
- Condition Hyperbilirubinemia
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Neonatal Jaundice, Hyperbilirubinemia
Compassionate Use of Stanate (TM) [Stannsoporfin]
The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria: 1.
- Trial name
- NCT00076960
- Testing
- Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
- Where
- United States
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Hyperbilirubinemia
Comparative Study of Phototherapy for Hyperbilirubinemia
Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care nurseries around the world. It is a condition in which there is too much bilirubin in the blood.
- Trial name
- NCT00635375
- Testing
- LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy), Metal halide phototherapy (Spot PT metal halide phototherapy), LED bank phototherapy (Natus neoBlue LED bank phototherapy)
- Where
- 2 sites in United States
- Volunteers
- 82 people
- Sponsor
- GE Healthcare
Hyperbilirubinemia
Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical…
- Trial name
- NCT02685189
- Testing
- Previous exposure to stannsoporfin
- Volunteers
- 55 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Neonatal Jaundice
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.
- Trial name
- allphones (NCT05955144)
- Testing
- Picterus JP
- Where
- Norway
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Neonatal Jaundice
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.
- Trial name
- NCT05365399
- Testing
- smartphone-based screening tool for neonatal jaundice
- Where
- Uganda
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Neonatal Jaundice
Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.
- Trial name
- NCT06329843
- Testing
- Picterus Jaundice Pro (JP)
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Nutritional and Metabolic Diseases
Efficacy and Safety of Stannsoporfin in Neonates
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the…
- Trial name
- NCT02685137
- Testing
- stannsoporfin
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Newborn Jaundice
BiliCam Clinical Validation Study
The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in…
- Trial name
- NCT03246503
- Testing
- BiliCam estimated bilirubin (BCB)
- Where
- United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- BiliCam, LLC
Cerebrotendinous Xanthomatosis
The Prevalence of CTX Disorder in Juvenile Cataract Cases in Turkey
Epidemiologic observational study. Study will include two phases: 1. Retrospective cross-sectional phase: At this stage of the study, retrospective screenings are carried out at study sites and all juvenile cataract cases are…
- Trial name
- GEN-EYE-I (NCT03584893)
- Testing
- Blood sampling for Cholestanol Analysis
- Where
- 36 sites in Turkey (Türkiye)
- Volunteers
- 1,000 people
- Sponsor
- TRPHARM
Jaundice, Neonatal
Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana
The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.
- Trial name
- NCT06372093
- Testing
- Picterus Jaundice Pro
- Where
- Botswana
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Hyperbilirubinemia, Neonatal Jaundice
Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
The Canadian Pediatric Society recently published guidelines to monitor bilirubin levels and as part of standard of care all hospitalized newborns are routinely monitored for the development of high bilirubin or jaundice every…
- Trial name
- NCT02774434
- Testing
- JM-105
- Where
- 3 sites in Canada
- Volunteers
- 464 people
- Sponsor
- Draeger Medical Systems, Inc.
Jaundice, Neonatal
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia.
- Trial name
- NCT05630495
- Testing
- Picterus Jaundice Pro
- Where
- 2 sites in Indonesia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Jaundice, Neonatal
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP
- Trial name
- NCT05650463
- Testing
- Picterus Jaundice Pro
- Where
- Sweden
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Jaundice, Neonatal Hyperbilirubinemia
Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993). No interventions were administered during this follow-up study.
- Trial name
- NCT02033096
- Testing
- Stannsoporfin, Phototherapy (as needed)
- Volunteers
- 42 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Urea Cycle Disorders, Crigler Najjar Syndrome
Safety Study of HepaStem for the Treatment of Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN)
The purpose of this study is to assess the safety and to appraise the efficacy of one cycle of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in paediatric patients suffering from CN or UCD.
- Trial name
- HEP001 (NCT01765283)
- Testing
- HepaStem
- Where
- 11 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Cellaion SA
Newborn Jaundice
Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm
Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia.
- Trial name
- Bili-PrediX1 (NCT05121311)
- Testing
- NeoprediX B1 algorithm
- Where
- 2 sites in Germany
- Volunteers
- 455 people
- Sponsor
- NeoPredix AG
Urea Cycle Disorders, Crigler Najjar Syndrome
Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001)
The purpose of this study is to assess the long-term safety follow-up of patients having been treated with HepaStem.
- Trial name
- NCT02051049
- Where
- Belgium
- Volunteers
- 9 people
- Sponsor
- Cellaion SA
Urea Cycle Disorder, Crigler-Najjar Syndrome
HepaStem Long-Term Safety Registry
All patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by Promethera Biosciences
- Conditions
- Urea Cycle Disorder, Crigler-Najjar Syndrome, Acute on Chronic Liver Failure
- Trial name
- PROLONGSTEM (NCT03343756)
- Where
- 29 sites in Belgium, Bulgaria and 3 more
- Volunteers
- 44 people
- Sponsor
- Cellaion SA
Hyperbilirubinemia, Neonatal
Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat…
- Trial name
- JASMINE_205 (NCT02000830)
- Testing
- Stannsoporfin
- Volunteers
- 68 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Neonatal Jaundice
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color…
- Trial name
- NCT05521607
- Testing
- Picterus Jaundice Pro (JP)
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Picterus AS