Clinical trials: Hepatic Fibrosis
- Condition Hepatic Fibrosis
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Advanced Chronic Liver Disease, Healthy Participants
A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine
The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.
- Trial name
- NCT06974565
- Testing
- AZD2389, Quinidine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 Given to Healthy Participants
This is a study of experimental medication BMS-986036 given to healthy participants.
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03445208
- Testing
- BMS-986036
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Participants
A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
- Trial name
- NCT06846528
- Testing
- AZD2389, Itraconazole
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Fibrosis
QTc Assessment in a Single-Dose Study of Hydronidone Capsules
This study was designed with three dose cohorts (A1-A3): a 90 mg cohort, a 270 mg cohort, and a 540 mg cohort. Each cohort enrolled 16 healthy Chinese participants, with 12 receiving the investigational product Hydronidone…
- Trial name
- NCT07263152
- Testing
- Hydronidone
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Liver Fibrosis, Hepatitis C Virus
Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)
This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the groundwork for the validation of MRE as an…
- Trial name
- NCT00896233
- Testing
- MRE
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the…
- Trial name
- NCT02581592
- Testing
- TD-4208
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Healthy Participants
Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
- Trial name
- NCT05604287
- Testing
- ID119031166M
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Advanced Chronic Liver Disease, Healthy Participants
A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants
The purpose of this study is to measure the effect of multiple doses of AZD2389 on the pharmacokinetics (PK) of midazolam, caffeine, and bupropion in healthy participants.
- Trial name
- CRIOLLO (NCT06973005)
- Testing
- AZD2389, Midazolam, Caffeine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatitis B
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic…
- Trial name
- NCT04971928
- Testing
- GSK3228836
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Cirrhosis
Spleen Stiffness Measurement With FibroScan
FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in Europe since December 2003 and is currently used in many countries.
- Trial name
- NCT02180113
- Testing
- Fibroscan® examination
- Where
- 7 sites in France, Italy and 2 more
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- Echosens
Non-alcoholic Steatohepatitis, Liver Diseases
Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI
This is a prospective observational study which will recruit up to 100 paediatric participants over a period of 30 months to determine whether MRI is as accurate at detecting, distinguishing, and monitoring liver disease as…
- Conditions
- Non-alcoholic Steatohepatitis, Liver Diseases, Liver Fibroses, Autoimmune Hepatitis
- Trial name
- Kids4LIFe (NCT03198104)
- Testing
- MRI
- Where
- Poland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Perspectum
Hepatic Impairment
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- CAMPOLINA (NCT06812780)
- Testing
- AZD2389
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Liver Fibrosis
The Phase Ⅰd Clinical Trial of Hydronidone Capsules
Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose…
- Trial name
- NCT07262346
- Testing
- Hydronidone capsules
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH)
The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
The main purpose of this study is to compare the effectiveness of various non-invasive elastography techniques at determining liver stiffness measures in human subjects.
- Conditions
- Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Liver Fibroses, Liver Steatoses
- Trial name
- NCT04682600
- Testing
- Liver Incytes System
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Sonic Incytes
Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Study in Healthy Adults Evaluating PF-07202954
The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
- Trial name
- NCT04857437
- Testing
- PF-07202954 Repeat Dose, PF-07202954 Single Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Hepatitis B-related Liver Fibrosis
[¹⁴C] Hydronidone Mass Balance Study
According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it…
- Trial name
- NCT07471217
- Testing
- [¹⁴C]Hydronidone
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
In Development for Cystic Fibrosis
Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.
- Trial name
- NCT01208285
- Testing
- VX-770
- Where
- 3 sites in Czechia, Slovakia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.
- Trial name
- NCT05437120
- Testing
- VX-121/TEZ/D-IVA
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated