Clinical trials: Fibrosis
Pulmonary Fibrosis, COVID-19 Respiratory Infection
Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
The COVID-induced fibrotic lung damage continues long after viral infection has subsided and is exhibited by severe respiratory pathology and concomitant symptoms.
- Trial name
- NCT05387239
- Testing
- VL-PX10 and VL-P22 plus standard care
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Vitti Labs, LLC
Exocrine Pancreatic Insufficiency, Steatorrhea
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic…
- Conditions
- Exocrine Pancreatic Insufficiency, Steatorrhea, Malabsorption Syndromes, Cystic Fibrosis
- Trial name
- NCT00662675
- Testing
- Pancrease MT 10.5, or MT 21
- Where
- 11 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Cystic Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.
- Trial name
- NCT02347657
- Testing
- VX-661 Plus Ivacaftor Combination, Ivacaftor
- Where
- 74 sites in United States, Canada and 10 more
- Volunteers
- 510 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Idiopathic Pulmonary Fibrosis, Cough
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)
Orally administered ME-015 (Suplatast Tosilate) has been available on the market as a prescription drug for allergy-related conditions in Japan since 1995 with a good safety and tolerability profile.
- Conditions
- Idiopathic Pulmonary Fibrosis, Cough, IPF, Fibrotic Lung Disease
- Trial name
- COSMIC-IPF (NCT05983471)
- Testing
- ME-015 (Suplatast Tosilate)
- Where
- 6 sites in India
- Volunteers
- 40 people
- Sponsor
- Melius Pharma AB
Pulmonary Fibrosis
Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)
The purpose of this study is to determine whether NAC added to prednisone, and azathioprine has a better effect on lung function, radiology and clinical condition than placebo + prednisone in combination with azathioprine after 6…
- Trial name
- IFIGENIA (NCT00639496)
- Testing
- n-acetylcysteine
- Where
- 7 sites in Belgium, France and 5 more
- Volunteers
- 184 people
- Sponsor
- Zambon SpA
Cystic Fibrosis
Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants
The purpose of this study is to evaluate the effect of multiple doses of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) on the PK of rosuvastatin and the safety and tolerability of coadministration of VNZ/TEZ/D-IVA with…
- Trial name
- NCT07349394
- Testing
- VNZ/TEZ/D-IVA, Rosuvastatin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
Cystic Fibrosis
International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF1 (NCT00112359)
- Testing
- AZLI 75 mg three times a day (TID)
- Where
- 53 sites in United States, Australia and 2 more
- Volunteers
- 166 people
- Sponsor
- Gilead Sciences
Idiopathic Pulmonary Fibrosis
To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
Primary Objective: To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period.
- Trial name
- NCT01529853
- Testing
- SAR156597
- Where
- 21 sites in United States, Canada and 3 more
- Volunteers
- 24 people
- Sponsor
- Sanofi
Acute Episode of Overt Hepatic Encephalopathy, Hepatic Encephalopathy
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
- Trial name
- STOP-HE (NCT01966419)
- Testing
- ornithine phenylacetate
- Where
- 131 sites in United States, Australia and 15 more
- Volunteers
- 231 people
- Sponsor
- Ocera Therapeutics, Inc.
Solid Tumor, Obesity
Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects
This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans.
- Conditions
- Solid Tumor, Obesity, Idiopathic Pulmonary Fibrosis
- Trial name
- NCT07682337
- Testing
- SCB0020160
- Where
- Australia
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- SCBIO Inc.
Liver Fibrosis
Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination
This is an European, prospective, interventional, and multicenter exploratory clinical investigation that will take place in 6 French sites and 200 patients will be included (adults and children).
- Trial name
- NCT04747457
- Testing
- Research FibroScan
- Where
- 6 sites in France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Echosens
Liver Transplantation
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate…
- Trial name
- RAD (NCT00622869)
- Testing
- Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control)
- Where
- 91 sites in United States, Argentina and 17 more
- Volunteers
- 719 people
- Sponsor
- Novartis Pharmaceuticals
Moderate Liver Impairment, Severe Liver Impairment
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment.
- Trial name
- NCT04634149
- Testing
- BMS-986036
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Cystic Fibrosis
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy.
- Trial name
- SAAVe (NCT06526923)
- Testing
- SP-101 and doxorubicin Cohort 1, SP-101 and doxorubicin Cohort 2
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Spirovant Sciences, Inc.
Cholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
- Trial name
- NCT06825559
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zydus Therapeutics Inc.
Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Emotional and Social Experiences of Antifibrotic (AF) Therapy Among Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF) Patients: A Real-World Study
This is a cross-sectional study that will be conducted across Japan using an online patient-reported outcome questionnaire. This study tries to find out the attitudes toward and experiences of the emotional and/or social impact…
- Trial name
- NCT07743996
- Where
- Japan
- Volunteers
- 122 people
- Sponsor
- Boehringer Ingelheim
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Liver Fibrosis, Liver Steatosis
The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis.
- Trial name
- NCT03957070
- Testing
- Liver Incyte
- Where
- 2 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Sonic Incytes
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC