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Fibrosis clinical trials at UC Health
36 in progress, 22 open to eligible people

  • A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

    open to eligible people ages 40-80

    This phase 2 clinical study will be a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

    at UCLA UCSF

  • A Research Study to Test the Safety and Effectiveness of Experimental Treatment With Inhaled Nitric Oxide for Pulmonary Fibrosis

    “This study aims to find out if the study drug, nitric oxide, may help treat pulmonary fibrosis (PF).”

    open to eligible people ages 18-85

    A phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in subjects with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2).

    at UCLA UC Davis

  • A Study of Experimental AeroVanc for MRSA Infection (a bacteria resistant to antibiotics) in Patients With Cystic Fibrosis

    “If you have cystic fibrosis and a chronic methicillin-resistant Staphylococcus aureus (MRSA) lung infection, help us test a new treatment.”

    open to eligible people ages 6 years and up

    This study is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.

    at UC Davis UCSD

  • A Study of Experimental Fenretinide (LAU-7b) for Cystic Fibrosis in Adults

    open to eligible people ages 18 years and up

    An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.

    at UC Davis

  • A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

    open to eligible people ages 18-75

    This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being replaced by scar tissue).

    at UCSD

  • A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

    open to eligible people ages 18-75

    This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe fibrosis).

    at UCSD

  • A Study of the Safety of Experimental CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis (decreased lung function)

    “The purpose of this study is to test an experimental drug called CC-90001 in patients with Idiopathic pulmonary fibrosis (IPF).”

    open to eligible people ages 40 years and up

    This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.

    at UC Davis

  • A Study to Evaluate experimental immuno-modulator in Subjects With Idiopathic Pulmonary Fibrosis

    open to eligible people ages 18 years and up

    This study is being conducted to evaluate the safety, tolerability, and activity of 400 mg of KD025 once-daily (QD) compared to Best Supportive Care(BSC) in male and postmenopausal/surgically sterilized female subjects with IPF.

    at UC Davis

  • AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

    open to eligible people ages 18-75

    The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

    at UCSF UCSD

  • Best course of antibiotic treatment for patients with Cystic Fibrosis pulmonary exacerbation

    “Does 10 days of antibiotics work as well as 14? Help us determine what is the optimal treatment for patients with CF pulmonary exacerbation”

    open to eligible people ages 18 years and up

    Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations are treated with varying antibiotics for varying time periods based on needs determined by individual patients, their families, and the health care providers. Cystic fibrosis pulmonary guidelines for the treatment of pulmonary exacerbation published by the Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also identified key questions for which additional studies were needed. A strong desire among clinicians to reduce treatment durations (and reduce cost, inconvenience, and potential toxicities) is in conflict with belief that patients not responding robustly to treatment might benefit from extending treatment. This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.

    at UCSD UC Davis

  • CF And Effects of Drugs Mixed Ex Vivo With Sputum for Mucolytic Treatment

    open to eligible people ages 18-65

    The investigators will collect samples of sputum from healthy volunteers and patients with cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding studies and; b) assessment of the effects of carbohydrates on the rheologic properties of the sputum. This study has two hypotheses: 1. Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in a fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic compounds. 2. Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF sputum.

    at UCSF

  • CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes

    open to eligible people ages 4 months and up

    This is a multicenter, cross-sectional, cohort study which will collect contemporary SC values from approximately 1000 CF patients prescribed and currently receiving commercially approved CFTR modulator therapies.

    at UCSD

  • CleanUP IPF for the Pulmonary Trials Cooperative

    “The study team thinks long-term antibiotic therapy can reduce hospital stays for respiratory problems.”

    open to eligible people ages 40 years and up

    The purpose of this study is to compare the effect of standard care, versus standard of care plus antimicrobial therapy (co-trimoxazole or doxycycline), on clinical outcomes in patients diagnosed with idiopathic pulmonary fibrosis (IPF).

    at UC Davis

  • Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.

    open to eligible people ages 40-70

    This is a two part study. In the first part, the pharmacokinetic profile of Epigallocatechin-3-gallate (EGCG) in normal human volunteers given a single oral dose will be determined to set the dose for the second part of the study. In the second part of this study, lung biopsy fragments and urine samples from patients with interstitial lung disease treated with EGCG will be evaluated in biochemical assays and compared to samples from untreated control patients.

    at UCSF

  • Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestin...

    open to eligible people ages up to 99 years

    This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

    at UCSD UC Davis UCSF

  • Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis

    “Comparison of imaging techniques used to evaluate patients with liver disease”

    open to eligible people ages 18 years and up

    The goal of this study is to evaluate non-invasive imaging techniques for determining liver steatosis (fat), inflammation (abnormal tissue swelling), and fibrosis (abnormal tissue scarring).In addition, the study group will be using other test measures including personal demographics, laboratory blood test results, and imaging measurements to determine the severity of NAFLD (non-alcoholic fatty liver disease), NASH (non-alcoholic steatohepatitis), inflammation, and fibrosis.

    at UC Davis

  • Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

    open to eligible people ages 18-75

    The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

    at UCSF UCSD UC Davis

  • Pulmonary Fibrosis Foundation Patient Registry

    open to eligible people ages 18-99

    The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research

    at UCLA UCSF

  • Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

    open to eligible people ages 18-85

    The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

    at UCSF UCSD UCLA UC Davis

  • Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa Infection

    open to eligible people ages 3 months to 18 years

    The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new onset Pseudomonas aeruginosa respiratory tract infection.

    at UCSF

  • Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE

    open to eligible people ages 18 years and up

    This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

    at UCSF UCSD UC Davis

  • Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis

    open to eligible people ages 40-80

    This study will investigate the safety and efficacy of VAY736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks. Approximately, 84 subjects will be randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo.

    at UCLA

  • A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

    Sorry, in progress, not accepting new patients

    This study will evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

    at UC Davis UCSF

  • A Study of Experimental Inhaled Treprostinil For Pulmonary Hypertension due to Parenchymal Lung Disease (scarred lung tissue)

    Sorry, accepting new patients by invitation only

    This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).

    at UCSF UCSD UC Davis

  • A Study of Experimental INS1007 For Non-Cystic Fibrosis Bronchiectasis (damage to airways, making it difficult to clear mucus)

    Sorry, in progress, not accepting new patients

    The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in patients with non-cystic fibrosis bronchiectasis.

    at UC Davis

  • A Study of the Long-Term Safety of the Experimental Medicine Nintedanib For Lung Fibrosis (damaged lung tissue)

    Sorry, not currently recruiting here

    The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

    at UCLA UC Davis UCSF

  • A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

    Sorry, in progress, not accepting new patients

    This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.

    at UCSF

  • Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection

    Sorry, not accepting new patients

    The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.

    at UCSF

  • Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

    Sorry, in progress, not accepting new patients

    Drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations. This is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have IPF and those who do not. The people who have IPF will be followed for 12 months to collect more biological samples and record clinically relevant information. The goal of this study is to identify new molecular markers that are measurable and reliable in people who have IPF. It is hoped that these markers can be used in future drug studies to significantly speed up the process of finding drugs that help.

    at UCSF

  • Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis

    Sorry, in progress, not accepting new patients

    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. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.

    at UCLA UC Davis UCSD

  • Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

    Sorry, in progress, not accepting new patients

    The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

    at UCLA UCSF

  • FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

    Sorry, accepting new patients by invitation only

    Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and quantify liver fibrosis.

    at UCSF

  • Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry

    Sorry, not currently recruiting here

    This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts. For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts.

    at UCLA UC Davis

  • Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis

    Sorry, accepting new patients by invitation only

    This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in the CENTAUR study 652-2-203 [NCT02217475].

    at UCSD

  • Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

    at UCSD UC Davis UCSF

  • Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With CF

    Sorry, not currently recruiting here

    This is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa.

    at UCSD

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