Clinical trials: Hepatobiliary Disorders
Chronic Liver Disease
Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference
Chronic liver diseases (CLDs) represent a major worldwide public health burden. Worldwide estimations show that 844 million people have CLDs, a lot more than other chronic diseases such as diabetes or cardiovascular diseases.
- Trial name
- NCT03704792
- Testing
- FibroScan 530 Compact
- Where
- 5 sites in France
- Volunteers
- 207 people
- Sponsor
- Echosens
Alagille Syndrome
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and…
- Trial name
- ITCH (NCT02057692)
- Testing
- LUM001
- Where
- 13 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis C, Chronic
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent…
- Trial name
- NCT00516321
- Testing
- eltrombopag
- Where
- 191 sites in United States, Australia and 23 more
- Volunteers
- 687 people
- Sponsor
- GlaxoSmithKline
Hepatic Encephalopathy
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.
- Trial name
- AST015 (NCT00558038)
- Testing
- AST-120, lactulose
- Where
- 17 sites in United States
- Volunteers
- 40 people
- Sponsor
- Ocera Therapeutics
Non-alcoholic Steatohepatitis
Investigate Safety, Tolerability, PK/PD of J2H-1702 in Healthy Females
Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects.
- Trial name
- NCT06308874
- Testing
- Amg dose administration group, Bmg dose administration group
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- J2H Biotech
Non-alcoholic Steatohepatitis, Fibrosis
Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis
This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist.
- Conditions
- Non-alcoholic Steatohepatitis, Fibrosis, Liver Diseases
- Trial name
- ENCORE-NF (NCT02686762)
- Testing
- Emricasan (5 mg), Emricasan (50 mg)
- Where
- 103 sites in United States, Germany and 1 more
- Volunteers
- 318 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Solid Tumor
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR…
- Trial name
- NCT01752920
- Testing
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range
- Where
- 12 sites in United States, Italy
- Volunteers
- 119 people
- Sponsor
- Basilea Pharmaceutica
Non Alcoholic Steatohepatitis
Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis
This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH.
- Trial name
- EVIDENCES VI (NCT03863574)
- Testing
- Saroglitazar Magnesium 2mg, Saroglitazar Magnesium 4mg
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Zydus Therapeutics Inc.
Coagulation Protein Disorders, Blood Loss, Surgical
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation).
- Conditions
- Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care
- Trial name
- NCT01053169
- Testing
- Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N, Fresh Frozen Plasma
- Where
- 6 sites in United Kingdom
- Volunteers
- 445 people
- Sponsor
- CSL Behring
NASH - Nonalcoholic Steatohepatitis, NAFLD
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
A multi-centre randomised controlled trial to determine the implementation and health care cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic fatty liver disease (NAFLD) across several…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, Metabolic Syndrome
- Trial name
- RADIcAL1 (NCT03289897)
- Testing
- LiverMultiScan
- Where
- 11 sites in Germany, Netherlands and 2 more
- Volunteers
- 801 people
- Sponsor
- Perspectum
Chronic Liver Disease, NASH - Nonalcoholic Steatohepatitis
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects
A Phase 1a, Double Blind, Placebo-Controlled, Single-Center, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Volunteers
- Trial name
- NCT04146805
- Testing
- BLD-0409
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Blade Therapeutics
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Steatotic Liver Disease
German SLD-Registry (Deutsches SLD-Register)
Characterization of patients with steatotic liver disease (SLD) The German SLD-Registry (Deutsches SLD-Register) a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Leberstiftungs-GmbH Deutschland.
- Trial name
- NCT04721665
- Where
- 14 sites in Germany
- Volunteers
- 1,681 people
- Sponsor
- Leberstiftungs-GmbH Deutschland
Non-alcoholic Fatty Liver Disease (NAFLD)
Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)
This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods.
- Trial name
- NCT01110577
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC
Alpha-1 Antitrypsin Deficiency (AATD)
A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD)
This is a Phase 1/2, open-label, multi-center, dose escalation (Part 1), dose expansion (Part 2), and single repeat dose (Part 3) study to evaluate the safety, tolerability, efficacy, and PK/PD parameters of TSRA-196 in adults…
- Trial name
- NCT07227207
- Testing
- TSRA-196
- Where
- 9 sites in United States, Australia and 2 more
- Volunteers
- 72 people
- Sponsor
- Tessera Therapeutics, Inc.
Hepatobiliary Disorders, Non-alcoholic Steatohepatitis
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis
- Trial name
- NCT02970942
- Testing
- Semaglutide
- Where
- 158 sites in United States, Australia and 15 more
- Volunteers
- 320 people
- Sponsor
- Novo Nordisk A/S
Non-alcoholic Steatohepatitis
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of single and multiple doses of ARO-HSD in healthy adult volunteers and in patients with NASH or suspected NASH.
- Trial name
- NCT04202354
- Testing
- ARO-HSD Injection, sterile normal saline (0.9% NaCl)
- Where
- New Zealand
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Nonalcoholic Steatohepatitis
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of…
- Trial name
- NASH-FX (NCT02421094)
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Galectin Therapeutics Inc.
Hepatic Cirrhosis
Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)
- Trial name
- NCT00856713
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Norgine
Non Alcoholic Steatohepatitis (NASH)
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis…
- Trial name
- NCT04880187
- Testing
- AXA1125
- Where
- 75 sites in United States, Australia and 5 more
- Volunteers
- 273 people
- Sponsor
- Axcella Health, Inc