Clinical trials: Gastrointestinal Failure
Acute on Chronic Hepatic Failure, Acute Liver Failure
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver…
- Conditions
- Acute on Chronic Hepatic Failure, Acute Liver Failure, Liver Cirrhosis, Acute Alcoholic Hepatitis
- Trial name
- NCT01937130
- Testing
- IDN-6556
- Where
- 26 sites in United States, United Kingdom
- Volunteers
- 23 people
- Sponsor
- Conatus Pharmaceuticals Inc.
End-stage Liver Disease (ESLD), Liver Transplant
A Physical Activity Program in End-state Liver Disease
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program.
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness
- Trial name
- NCT02776553
- Testing
- Nutritional consultation, Physical training program, Behavioral modification therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Arkansas
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
Hepatitis C
Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)
This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) [PR] treatment in treatment-naïve and prior PR treatment failure participants…
- Trial name
- NCT02358044
- Testing
- Sofosbuvir, PegIntron, Ribavirin
- Volunteers
- 257 people
- Sponsor
- Merck Sharp & Dohme LLC
Liver Failure, Carcinoma, Hepatocellular
Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver Transplantation (OLT).
- Trial name
- NCT02635347
- Testing
- Remote Ischemic Conditioning (RIC), Pneumatic tourniquet
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Rutgers, The State University of New Jersey
Colorectal Neoplasms, Liver Neoplasms
A Study of Yttrium-90 Radioactive Resin Microspheres to Treat Colorectal Adenocarcinoma Metastatic to the Liver
The purpose of this study is to determine the effectiveness of radioactive microsphere infusion as a treatment for liver metastases from colon or rectal cancer.
- Trial name
- NCT01098422
- Testing
- Yttrium-90 Radioactive Resin Microspheres
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Tony Reid, M.D., Ph.D.
Left Sided Heart Failure, Left Ventricular Assist Device
Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial
This study evaluates two different methods for monitoring a patient's anti-clotting [heparin] therapy after they receive a heart pump implant [left ventricular assist device -LVAD].
- Conditions
- Left Sided Heart Failure, Left Ventricular Assist Device, Anticoagulant Therapy, Gastro Intestinal Bleeding
- Trial name
- VAD-ANTIX (NCT03143569)
- Testing
- aPTT guided heparin management, Anti-factor Xa guided heparin management
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
Metastatic Colorectal Cancer (mCRC)
Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients
Patients with metastatic colorectal cancer (mCRC) who have received all approved standard treatments (except Regorafenib and Lonsurf) no longer have treatment options available while maintaining a good performance status which…
- Trial name
- NEXT-REGIRI (NCT03829462)
- Testing
- Regorafenib, Irinotecan
- Where
- 11 sites in France
- Volunteers
- 377 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Chronic Hepatitis C, Hepatitis C Virus
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis, Severe Renal Impairment
- Trial name
- NCT02207088
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, Ribavirin
- Volunteers
- 68 people
- Sponsor
- AbbVie
Metastatic Colorectal Cancer
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved…
- Trial name
- NCT01103323
- Testing
- Regorafenib (Stivarga, BAY73-4506), Best Supportive Care (BSC)
- Where
- 171 sites in United States, Argentina and 17 more
- Volunteers
- 760 people
- Sponsor
- Bayer
End Stage Renal Disease, Hepatitis C
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time.
- Trial name
- NCT03627299
- Testing
- 300mg glecaprevir/pibrentasivir 120mg
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Johns Hopkins University
End Stage Liver Disease, Decompensated Cirrhosis of Liver
Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are: Model 1: Consultative Palliative Care (i.e.
- Trial name
- PAL-LIVER (NCT03540771)
- Testing
- Palliative Care
- Where
- 19 sites in United States
- Volunteers
- 1,494 people
- Sponsor
- Albert Einstein Healthcare Network
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Hepatic Encephalopathy
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).
- Trial name
- NCT00298038
- Testing
- Rifaximin
- Volunteers
- 299 people
- Sponsor
- Bausch Health Americas, Inc.
Acute Liver Failure, Fulminant Hepatic Failure
Study of N-Acetylcysteine in Acute Liver Failure (ALF)
This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with acute liver failure.
- Trial name
- ONAC (NCT00896025)
- Testing
- N-acetylcysteine
- Where
- 21 sites in United States
- Volunteers
- 255 people
- Sponsor
- University of Texas Southwestern Medical Center
Hepatic Encephalopathy
Manganese in Women With Encephalopathy
Objective: Report manganese serum levels and mortality in encephalopathic patients. Patients and participants: Consecutive patients aged > 18 years, with hepatic encephalopathy and informed consent signed by their families.
- Trial name
- NCT00985010
- Where
- Mexico
- Volunteers
- 9 people
- Sponsor
- Materno-Perinatal Hospital of the State of Mexico
Dysphagia
Aspiration in Acute Respiratory Failure Survivors
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.
- Trial name
- NCT02363686
- Testing
- FEES, BSE
- Where
- 3 sites in United States
- Volunteers
- 248 people
- Sponsor
- University of Colorado, Denver
Acute-On-Chronic Liver Failure
TAK-242 in Patients With Acute Alcoholic Hepatitis
A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of…
- Trial name
- NCT04620148
- Testing
- TAK-242
- Where
- 3 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- Akaza Bioscience Ltd
Intestinal Failure, CRBSI - Catheter Related Bloodstream Infection
8.4% Sodium Bicarbonate Locks in Intestinal Failure
We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for…
- Trial name
- NCT05813535
- Testing
- Sodium bicarb lock
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Riad Rahhal