Decompensated Cirrhosis Clinical Trial
Official title:
Companion Protocol for the ¹³C-Methacetin Breath Test Using the BreathID® MCS System for Conatus Phase 2 Study of Emricasan, an Oral Caspase Inhibitor, Under Protocol IDN-6556-17
This study is a companion protocol that will use the data generated by Conatus' study of emricasan under protocol IDN-6556-17.The IDN-6556-17 study is a Phase 2, multicenter, double-blind, placebo-controlled trial of Emricasan in subjects with decompensated non-alcoholic steatohepatitis (NASH) cirrhosis.
The protocol is intended to validate the ability of the MBT to predict deterioration by 48 weeks for all subjects, and at later time points for those followed longer, for subjects with decompensated NASH cirrhosis in the placebo treatment arm of Conatus' study IDN-6556-17. As one of the Conatus' study secondary objectives, this companion protocol is designed to assess improvement in liver metabolic function as measured by Methacetin Breath Test (MBT) [ Time Frame: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks) ]. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01701687 -
Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease
|
N/A | |
| Recruiting |
NCT05121870 -
Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis
|
Phase 2 | |
| Recruiting |
NCT05421351 -
Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
|
||
| Not yet recruiting |
NCT05086536 -
Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis
|
||
| Recruiting |
NCT03820271 -
New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation
|
N/A | |
| Recruiting |
NCT06134544 -
Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis
|
N/A | |
| Recruiting |
NCT06223893 -
CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis
|
N/A | |
| Completed |
NCT02219477 -
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
|
Phase 3 | |
| Recruiting |
NCT05734001 -
Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures.
|
N/A | |
| Terminated |
NCT04775329 -
Primary Prophylaxis for Spontaneous Bacterial Peritonitis
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04422223 -
Prospective Cohort Study of Disease and Outcomes in Cirrhosis
|
||
| Recruiting |
NCT02786017 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis
|
Phase 1/Phase 2 | |
| Completed |
NCT01326949 -
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis
|
N/A | |
| Recruiting |
NCT06396897 -
Hospital @ Home Model of Care for Cirrhosis
|
||
| Not yet recruiting |
NCT06306781 -
A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis
|
N/A | |
| Recruiting |
NCT05227846 -
Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-1)
|
Phase 1 | |
| Not yet recruiting |
NCT05937048 -
Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D).
|
N/A | |
| Active, not recruiting |
NCT03205345 -
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
|
Phase 2 | |
| Not yet recruiting |
NCT05224960 -
Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2)
|
Phase 2 | |
| Terminated |
NCT04112199 -
A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites
|
Phase 2 |