Clinical trials: Hepatobiliary Disorders
Non-alcoholic Fatty Liver Disease
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and…
- Trial name
- ZENITH-1 (NCT07221227)
- Testing
- Efimosfermin alfa
- Where
- 91 sites in United States, Australia and 7 more
- Volunteers
- 1,200 people
- Sponsor
- GlaxoSmithKline
Liver Diseases, Hepatic Insufficiency
A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
The main purpose of this study is to measure how much of the study drug called baricitinib gets into the blood stream and how long it takes the body to get rid of it. Healthy participants and those with liver disease may enroll.
- Trial name
- NCT01870388
- Testing
- Baricitinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Heart Failure
A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Liver Disease and in Age-, Weight- and Gender-matched Healthy Participants
Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body.
- Trial name
- NCT04722562
- Testing
- Vericiguat (BAY1021189)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
NAFLD, NASH
A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH
This is a Phase 2 Study to evaluate the effect of DD01 treatment in overweight/obese patients with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH).
- Trial name
- NCT06410924
- Testing
- DD01
- Where
- 12 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neuraly, Inc.
Non-alcoholic Steatohepatitis
Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, divided into two parts. The first part is a single-dose escalation study (Part1,SAD study phase), and the second part is a…
- Trial name
- NCT06716905
- Testing
- ACT500 tablets
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Non-alcoholic Fatty Liver Disease (NAFLD), Dyslipidaemia
Study of ECC4703 With Sulfasalazine and Pitavastatin
Non-alcoholic fatty liver disease is a chronic, serious, life-threatening, inflammatory liver disease characterized by increased liver fat content, inflammation, and progressive fibrosis.
- Trial name
- NCT07726368
- Testing
- ECC4703, Sulfasalazine, Pitavastatin
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eccogene
Non-Alcoholic Steatohepatitis
BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH
This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings associated with of Non-Alcoholic…
- Trial name
- NCT02314026
- Testing
- Suspected NASH BreathID test with 13C-Octanoate, Suspected NASH Breath test with 13C Methacetin
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 140 people
- Sponsor
- Meridian Bioscience, Inc.
Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor
This study is researching an experimental drug called ALN-PNP. This study is focused on participants who are known to have nonalcoholic fatty liver disease (NAFLD), and a specific variant of the patatin-like phospholipase domain…
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Genetic Risk Factor
- Trial name
- NCT06024408
- Testing
- ALN-PNP
- Where
- 5 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
Non-alcoholic Steatohepatitis (NASH)
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
- Trial name
- TANDEM (NCT03517540)
- Testing
- Tropifexor (LJN452), Cenicriviroc (CVC)
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 193 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Renal Insufficiency
- Trial name
- NCT03814005
- Testing
- Azacitidine, Pevonedistat
- Where
- 8 sites in United States, Spain
- Volunteers
- 17 people
- Sponsor
- Takeda
Liver Diseases, Liver Cirrhosis
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity…
- Conditions
- Liver Diseases, Liver Cirrhosis, Non-Alcoholic Fatty Liver Disease
- Trial name
- DIACEPA (NCT04782050)
- Testing
- Ultrasound liver assessment
- Where
- France
- Volunteers
- 100 people
- Sponsor
- E-Scopics
Genotype 1 Chronic Hepatitis C
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects.
- Trial name
- NCT00606086
- Testing
- GI-5005, Pegylated Interferon and Ribavirin
- Where
- 25 sites in United States
- Volunteers
- 140 people
- Sponsor
- GlobeImmune
Thrombocytopenia Associated With Chronic Liver Disease
A Study to Evaluate the Safety and Efficacy of PN20 in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
The main aim of this clinical trial is to assess the safety and efficacy of a single dose of PN20 in treatment of thrombocytopenia in adult patients with chronic liver disease undergoing an elective procedure.
- Trial name
- NCT07446491
- Testing
- PN20
- Where
- 8 sites in China
- Volunteers
- 54 people
- Sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
Chronic Liver Disease
In Patients With Chronic Liver Diseases(Alcoholic Liver Disease and Non-Alcoholic Fatty Liver Disease), LAENNEC(Human Placenta Hydrolysate) is to Evaluate the Efficacy and Safety of Intravenous Drop
Control group : LAENNEC subcutaneous injection (4 ml) Experimental group : LAENNEC intravenous injection (10 ml)
- Trial name
- NCT06493799
- Testing
- LAENNEC (Human Placenta Hydrolysate) IV, LAENNEC (Human Placenta Hydrolysate) SC
- Where
- South Korea
- Volunteers
- 226 people
- Sponsor
- Green Cross Wellbeing
NASH - Nonalcoholic Steatohepatitis
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.
- Trial name
- NCT05022693
- Testing
- BIO89-100
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- 89bio, Inc.
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
- Trial name
- NCT03684811
- Testing
- FT-2102, Azacitidine, Nivolumab
- Where
- 26 sites in United States, Australia and 4 more
- Volunteers
- 93 people
- Sponsor
- Forma Therapeutics, Inc.
Chronic Hepatitis B
Dose Escalation of Interleukin-1 (IL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B Virus (HBV) Infected Patients
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with anti viral therapy and vaccine in patients with Hepatitis B chronic infection.
- Trial name
- CONVERT (NCT01027065)
- Testing
- CYT107+GenHevac+entecavir or tenofovir, CYT107+ entecavir or tenofovir
- Where
- 8 sites in France, Italy
- Volunteers
- 24 people
- Sponsor
- Cytheris SA
Fontan, Right Heart Failure
Cholate Clearance in Fontan and Heart Failure
The goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease…
- Trial name
- NCT07009132
- Testing
- Dual cholate clearance assay, MRI
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- HepQuant, LLC
NASH - Nonalcoholic Steatohepatitis, NAFLD
Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, T2DM (Type 2 Diabetes Mellitus)
- Trial name
- NCT03291249
- Testing
- Foralumab, Omeprazole 20mg
- Sponsor
- Tiziana Life Sciences LTD
Alpha 1-Antitrypsin Deficiency
Study of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)
The purpose of this study is to evaluate the the safety and efficacy of the investigational product, fazirsiran (TAK-999, ARO-AAT), administered subcutaneously to patients with alpha-1 antitrypsin deficiency associated liver…
- Trial name
- NCT03946449
- Testing
- ARO-AAT
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 16 people
- Sponsor
- Arrowhead Pharmaceuticals