Clinical trials: Advanced Fibrosis
Hepatitis
Treating Nonalcoholic Steatohepatitis With Pioglitazone
Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol.
- Trial name
- NCT00062764
- Testing
- Actos (Pioglitazone)
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatocellular Carcinoma, Liver Cancer
Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer
This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC).
- Trial name
- NCT01264705
- Testing
- bavituximab (0.3 mg/kg) and sorafenib, bavituximab (1.0 mg/kg ) and sorafenib, bavituximab (3.0 mg/kg) and sorafenib
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- University of Texas Southwestern Medical Center
Cystic Fibrosis, Advanced Lung Disease
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation
- Trial name
- NCT02390219
- Testing
- Lumacaftor, Ivacaftor
- Where
- 6 sites in United States
- Volunteers
- 46 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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.
Hepatitis C
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced…
- Trial name
- NCT02319031
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 10 sites in Australia, France
- Volunteers
- 53 people
- Sponsor
- Bristol-Myers Squibb
Cirrhosis
A Study to Detect Advanced Liver Disease Via AI-enabled Electrocardiogram
The overall objectives of this study are to determine the effectiveness of ACE 2.0 model in early detection of advanced liver fibrosis, and to determine the acceptance and barriers for use of an AI-enabled algorithm for…
- Trial name
- ADVANCE (NCT05782283)
- Testing
- ACE (AI-Cirrhosis-ECG) 2.0
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- Mayo Clinic
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an…
- Trial name
- NCT03420768
- Testing
- BMS-986263
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Bristol-Myers Squibb
Liver Fibrosis Due to NASH
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants…
- Trial name
- NCT01672866
- Testing
- SIM
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 222 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus, Advanced Fibrosis
Study of Long-term Peg Intron vs. Colchicine in Non-responders.
In this study Peg-Intron will be tested to see if it will give better results than Colchicine. At this time, there is currently no recommended maintenance treatment for patients who have failed to respond to…
- Conditions
- Hepatitis C Virus, Advanced Fibrosis, Cirrhosis
- Trial name
- COPILOT (NCT00179413)
- Testing
- PEG -Intron, Colchicine
- Where
- 49 sites in United States
- Volunteers
- 549 people
- Sponsor
- Beth Israel Deaconess Medical Center
Hepatitis B, Chronic, Cirrhosis
Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis
This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed with biopsy.
- Conditions
- Hepatitis B, Chronic, Cirrhosis, Fibrosis, Chronic Hepatitis B
- Trial name
- NCT00347009
- Testing
- adefovir dipivoxil
- Where
- 12 sites in Hong Kong, Singapore and 3 more
- Volunteers
- 155 people
- Sponsor
- GlaxoSmithKline
Idiopathic Pulmonary Fibrosis
Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment
To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.
- Trial name
- NCT02802345
- Testing
- Nintedanib, Sildenafil
- Where
- 85 sites in United States, Australia and 11 more
- Volunteers
- 274 people
- Sponsor
- Boehringer Ingelheim
Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease
Interstitial lung disease (ILD) is the result of over 200 etiological pathways arising from several different insults to the lung parenchyma: inhaled substances, drug side effects, connective tissue disease, infection, and…
- Conditions
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Interstitial Pneumonitis, Desquamative Interstitial Pneumonia
- Trial name
- NCT02019641
- Testing
- Aerobic Exercise Training (AET), Education
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Hepatitis B, Chronic
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC).
- Trial name
- NCT02224456
- Testing
- Tenofovir disoproxil fumarate
- Where
- 19 sites in China
- Volunteers
- 197 people
- Sponsor
- GlaxoSmithKline
Chronic Liver Disease, Advanced Fibrosis
A Study to Evaluate Liver Stiffness With Shear Wave Elastography
The purpose of the study is to assess the diagnostic accuracy of Endoscopic Ultrasound (EUS) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis
- Conditions
- Chronic Liver Disease, Advanced Fibrosis, Advanced Cirrhosis
- Trial name
- NCT05097963
- Testing
- Endoscopic Ultrasound Shear Wave Elastography
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Mayo Clinic
Cirrhosis, Liver
Prophylactic Antibiotics in Admitted Cirrhotics
In this pilot study, the investigators aim to assess feasibility of subject identification and data collection, including specimen processing, as well as the rate of enrollment for a future, larger study of the effect of empiric…
- Trial name
- NCT04218695
- Testing
- Ceftriaxone, Normal saline
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Beth Israel Deaconess Medical Center
Fatty Liver, Nonalcoholic, Diabetes Mellitus, Type 2
Identification of Fatty Liver With Advanced Fibrosis in Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages
Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease worldwide and is a major cause of cirrhosis and liver cancer in Western countries.
- Trial name
- NCT04241575
- Testing
- Simple fibrosis scores and electronic reminder messages
- Where
- Hong Kong
- Volunteers
- 1,061 people
- Sponsor
- Chinese University of Hong Kong
Idiopathic Pulmonary Fibrosis
Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced…
- Trial name
- NCT02951429
- Testing
- Pirfenidone, Sildenafil
- Where
- 56 sites in Belgium, Canada and 11 more
- Volunteers
- 177 people
- Sponsor
- Hoffmann-La Roche
Liver Cirrhosis
Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis
The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for the treatment of patients with advanced liver cirrhosis.
- Trial name
- NCT01503749
- Testing
- G-colony stimulating factor, Infusion of the mobilized monocyte cells
- Volunteers
- 9 people
- Sponsor
- Seoul National University Hospital
Nonalcoholic Fatty Liver Disease (NAFLD)
Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease
This study will advance several goals of the NIH Action Plan: 1) establish a multidisciplinary team to develop quantitative methodologies and imaging protocols for liver, 2) validate diagnostic criteria and methodologies for…
- Trial name
- NCT01930123
- Testing
- intravenous fructose challenge, Blood Draw
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Manal F Abdelmalek