Clinical trials: Bilirubinemia
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, Pancreatic Cancer
Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.
The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.
- Trial name
- NCT02098239
- Testing
- G17DT
- Volunteers
- 41 people
- Sponsor
- Cancer Advances Inc.
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
Liver Failure
Recompensation of Exacerbated Liver Insufficiency With Hyperbilirubinemia and/or Encephalopathy and/or Renal Failure
The objective of this trial is to evaluate the impact of elimination of albumin bound substances during albumin dialysis (MARS®) on mortality and the clinical time course in patients with a recent severe clinical deterioration of…
- Trial name
- RELIEF (NCT00614146)
- Testing
- MARS device, Standard medical therapy
- Where
- 19 sites in Austria, Belgium and 7 more
- Volunteers
- 59 people
- Sponsor
- Vantive Health LLC
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
Alcoholic Hepatitis (AH)
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
- Trial name
- NCT02854631
- Testing
- Selonsertib, Prednisolone
- Where
- 44 sites in United States, Austria and 5 more
- Volunteers
- 104 people
- Sponsor
- Gilead Sciences
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
Jaundice, Obstructive
Remaxol® in Mechanical Jaundice of Non-malignant Origin
The purpose of this study is to assess the safety and efficacy of Remaxol (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia) infusions at dose 400 and 800 ml to treat mechanical jaundice of non-tumor cause…
- Trial name
- NCT03418935
- Testing
- Remaxol (succinate + methionine + inosine + nicotinamide), Ringer's Solution
- Where
- 13 sites in Russia
- Volunteers
- 342 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Adenocarcinoma of the Pancreas, Advanced Solid Tumors
QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas
AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival.
- Conditions
- Adenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer, Cancer of Pancreas
- Trial name
- GAMMA (NCT01231347)
- Testing
- AMG 479, gemcitabine
- Where
- 152 sites in United States, Australia and 30 more
- Volunteers
- 800 people
- Sponsor
- NantCell, Inc.
Pancreatic Neoplasms, Cholestasis
Pharmacokinetic and Safety Study of Nab®-Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubinemia
The purpose of this study is to determine the safety and pharmacokinetic profile of nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced pancreatic cancer who have cholestatic hyperbilirubinemia secondary to bile…
- Trial name
- NCT02267707
- Testing
- nab-paclitaxel, Gemcitabine
- Where
- 6 sites in United States, Germany
- Volunteers
- 1 people
- Sponsor
- Celgene
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
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
Biliary Tract Neoplasms, Pancreatic Neoplasms
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive…
- Conditions
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
- Trial name
- NCT00196105
- Testing
- 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, 10 mm Stainless Steel Wallstent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Cook Group Incorporated
Jaundice; Malignant
Remaxol® in Malignant Mechanical Jaundice
The trial intends to study the safety and efficacy of Remaxol® (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia),solution for infusion for the reduction of hyperbilirubinemia in patients with obstructive…
- Trial name
- NCT03416062
- Testing
- Remaxol®, Ringer's Solution
- Where
- 18 sites in Russia
- Volunteers
- 240 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical 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
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 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
Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
It is normal for red blood cells to die, even in newborn babies. The waste from that is called bilirubin. The liver clears bilirubin out of the body.
- Trial name
- JASMINE_204 (NCT01887327)
- Testing
- Phototherapy, Stannsoporfin
- Where
- 18 sites in United States
- Volunteers
- 91 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Jaundice, Neonatal
A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to…
- Trial name
- NCT05616845
- Testing
- Picterus Jaundice Pro
- Where
- Philippines
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Picterus AS
HIV/AIDS
Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir
The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.
- Trial name
- NCT02532673
- Volunteers
- 1,200 people
- Sponsor
- Bristol-Myers Squibb