Clinical trials: Neonatal Hyperbilirubinemia
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
Crigler-Najjar Syndrome
Gene Transfer Clinical Study in Crigler-Najjar Syndrome
This is a Phase 1/2, multinational, open-label, ascending-dose, delayed-treatment concurrent control clinical study to evaluate the safety and preliminary efficacy of AT342 in subjects with Crigler-Najjar aged ≥1 year.
- Trial name
- VALENS (NCT03223194)
- Testing
- AT342
- Where
- 4 sites in United States, Israel and 1 more
- Volunteers
- 1 people
- Sponsor
- Audentes Therapeutics
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
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
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
Jaundice, Neonatal
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.
- Trial name
- NCT05625880
- Testing
- Picterus Jaundice Pro
- Where
- Nepal
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Hyperbilirubinemia
Safety and Pharmacology of Stanate
The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.
- Trial name
- NCT00115544
- Testing
- Stanate
- Where
- Vietnam
- Volunteers
- 55 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
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
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.
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
Meulengracht Syndrome, Hyperbilirubinemia
Biomarker for Gilbert Disease (BioGilbert)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Gilbert disease from blood
- Conditions
- Meulengracht Syndrome, Hyperbilirubinemia, Unconjugated Benign Bilirubinemia
- Trial name
- BioGilbert (NCT02712138)
- Where
- 4 sites in Egypt, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
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
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
Jaundice, Neonatal
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.
- Trial name
- NCT05623566
- Testing
- Picterus Jaundice Pro
- Where
- 3 sites in Indonesia
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- Picterus AS
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
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
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
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
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