Clinical trials: Sinusoidal Obstruction Syndrome
Hepatic Veno-Occlusive Disease
Pediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of Defibrotide
The aim of this trial is to evaluate whether the prophylactic use of Defibrotide (DF) in pediatric patients (age less than 18 years) undergoing stem cell transplantation and who are at high risk of developing hepatic…
- Trial name
- VOD-DF (NCT00272948)
- Testing
- Defibrotide
- Where
- 30 sites in Austria, France and 8 more
- Volunteers
- 360 people
- Sponsor
- European Society for Blood and Marrow Transplantation
Sinusoidal Obstruction Syndrome, Veno-occlusive Disease
Defibrotide Dose-escalation for SOS Post-HSCT
This research study is being done to determine the safety and tolerability of increasing doses of defibrotide within a single patient with sinusoidal obstructive syndrome (SOS)/veno-occlusive disease (VOD) after hematopoietic…
- Trial name
- NCT05987124
- Testing
- Defibrotide
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- New York Medical College
Hepatic Veno-Occlusive Disease, Nephroblastoma
Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL
Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse.
- Conditions
- Hepatic Veno-Occlusive Disease, Nephroblastoma, Acute Lymphoblastic Leukemia
- Trial name
- MVO (NCT04168788)
- Testing
- Blood test for genetic analysis
- Where
- 11 sites in France
- Volunteers
- 85 people
- Sponsor
- University Hospital, Angers
Sinusoidal Obstruction Syndrome, Veno-occlusive Disease
5-day Defibrotide Treatment for Hepatic SOS/VOD
Sinusoidal Obstruction Syndrome (SOS), also referred to as hepatic veno-occlusive disease (VOD), is rare but serious complication of allogeneic stem cell transplantation (allo-SCT).
- Conditions
- Sinusoidal Obstruction Syndrome, Veno-occlusive Disease, Bone Marrow Transplant Complications
- Trial name
- NCT04313036
- Testing
- Defibrotide
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Loyola University
Veno Occlusive Disease, Hepatic, Sinusoidal Obstruction Syndrome
Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY)
ELASTOVOD is a prospective multicenter study, involving several centers of Onco-haematology in Italy. Investigators perform hepatic elastographic measurements (with Transient Elastography, ARFI or 2D-SWE) on patients undergoing…
- Conditions
- Veno Occlusive Disease, Hepatic, Sinusoidal Obstruction Syndrome, Stem Cell Transplant Complications
- Trial name
- ELASTOVOD (NCT03426358)
- Testing
- LSM assessed by Elastographic Techniques
- Where
- 37 sites in Italy
- Volunteers
- 1,101 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Liver Diseases
Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (Food and Drug Administration [FDA] approved) agents fails in most cases.
- Trial name
- NCT00263978
- Testing
- Defibrotide
- Where
- United States
- Sponsor
- Emory University
Bone Marrow Transplant Complications, Sinusoidal Obstruction Syndrome
Ultrasound Elastography to Predict Development of SOS
The long-term goal of our research is to accurately identify SOS patients who would benefit from defibrotide treatment using US SWE. The overall objective of this study is to validate SWE as an early diagnostic marker for SOS.
- Conditions
- Bone Marrow Transplant Complications, Sinusoidal Obstruction Syndrome, Veno-occlusive Disease, Stem Cell Transplant Complications
- Trial name
- NCT03858530
- Testing
- Ultrasound Examination
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Children's Mercy Hospital Kansas City
Veno-occlusive Disease
Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients
This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric…
- Trial name
- NCT02851407
- Testing
- Defibrotide, Best Supportive Care
- Where
- 114 sites in United States, Australia and 12 more
- Volunteers
- 372 people
- Sponsor
- Jazz Pharmaceuticals
Sinusoidal Obstruction Syndrome (SOS), Hematopoietic Stem Cell Transplant (HSCT)
Efficacy of N-acetylcysteine Versus Placebo as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation
Sinusoidal obstruction syndrome (SOS) or hepatic veno-occlusive disease (VOD) is a serious complication that occurs, most often occurring in patients undergoing hematopoietic stem cell transplantation (HSCT), especially in its…
- Trial name
- ALISON (NCT04712435)
- Testing
- N-acetylcysteine
- Where
- Brazil
- Volunteers
- 80 people
- Sponsor
- Instituto Brasileiro de Controle do Cancer
Sinusoidal Obstruction Syndrome
Detection of Sinusoidal Obstruction Syndrome With Ultrasound After Allogeneic HSCT
We would like conduct a real-life study in our center to evaluate the early detection of sinusoidal obstruction syndrome with hepatic ultrasound or elastography before allogeneic hematopoietic stem cell transplantation.
- Trial name
- NCT04141735
- Testing
- ultrasound
- Volunteers
- 114 people
- Sponsor
- Central Hospital, Nancy, France
Bone Marrow Transplant Complications, Sinusoidal Obstruction Syndrome
Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome
To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone…
- Conditions
- Bone Marrow Transplant Complications, Sinusoidal Obstruction Syndrome, Veno Occlusive Disease, Hepatic, Stem Cell Transplant Complications
- Trial name
- NCT03865589
- Testing
- Ultrasound Elastography
- Where
- 7 sites in United States
- Volunteers
- 250 people
- Sponsor
- Children's Mercy Hospital Kansas City
Hematopoietic Cell Transplantation
A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).
This is a prospective international multi-center registry and biorepository trial of children and adolescents/young adults (AYA) undergoing hematopoietic cell transplantation (HCT) to assess the impact of endotheliopathies in the…
- Trial name
- NCT05090345
- Testing
- Biorepository Trial
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- Duke University
Sinusoidal Obstruction Syndrome
Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study
The goal of this is to learn more about stem cell transplant and complications that some people have after their transplants, in particular sinusoidal obstruction syndrome (SOS), also called veno-occlusive disease of the liver.
- Trial name
- SOSBiomarker (NCT03132337)
- Testing
- Serial Blood Draws
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Indiana University
Pulmonary Veno-Occlusive Disease, Hepatic Veno-Occlusive Disease
Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients
The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of…
- Conditions
- Pulmonary Veno-Occlusive Disease, Hepatic Veno-Occlusive Disease, Mucositis
- Trial name
- NCT00563498
- Testing
- Glutamine
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Hospital Authority, Hong Kong
Hepatic Veno-Occlusive Disease
Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.
- Trial name
- NCT01886248
- Testing
- Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Seoul National University Hospital
Severe Hepatic Veno-Occlusive Disease
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of…
- Trial name
- NCT00358501
- Testing
- Defibrotide
- Where
- 25 sites in United States, Canada
- Volunteers
- 134 people
- Sponsor
- Jazz Pharmaceuticals
Sinusoidal Obstruction Syndrome, Veno Occlusive Disease, Hepatic
Validating Ultrasound Biomarkers for Hepatic Sinusoidal Obstruction Syndrome in Pediatric Hematopoietic Cell Transplant Patients
Hepatic veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) is a potentially fatal complication of hematopoietic cell transplant (HCT).
- Conditions
- Sinusoidal Obstruction Syndrome, Veno Occlusive Disease, Hepatic, Bone Marrow Transplant Complications, Stem Cell Transplant Complications
- Trial name
- NCT03963999
- Testing
- Ultrasound Elastography, Contrast Enhanced Ultrasound (CEUS)
- Where
- United States
- Sponsor
- Children's Mercy Hospital Kansas City
Colorectal Cancer, Liver Metastases
SAMe in Prevention of Oxaliplatin-associated Liver Injury
This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable…
- Conditions
- Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer, Liver Injury
- Trial name
- NCT06258525
- Testing
- Standard of care oxaliplatin-based chemotherapy, S-adenosylmethionine (SAMe) supplement, Surgery
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Cedars-Sinai Medical Center
Hepatic Veno-Occlusive Disease
European VOD Registry
Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic stem cell transplantation (HSCT), as a…
- Trial name
- NCT03032016
- Where
- 53 sites in France, Italy and 2 more
- Volunteers
- 176 people
- Sponsor
- Jazz Pharmaceuticals
Sinusoidal Obstruction Syndrome, Complications of Bone Marrow Transplant
Using Ultrasound Elastography to Predict Development of SOS
Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive disease-affecting children following bone marrow transplantation (BMT).
- Trial name
- NCT02483481
- Testing
- shear wave ultrasound elastography
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Children's Mercy Hospital Kansas City