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Fibrosis clinical trials at UC Health
36 in progress, 18 open to new patients

  • 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 18-80

    A phase 2b, randomized, double-blind, placebo-controlled 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

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

    open to eligible people ages 18-85

    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 Experimental VX-445 Combination Therapy For Cystic Fibrosis With F508del Genetic Mutation

    open to eligible people ages 12 years and up

    This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

    at UC Davis UCSF

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

    open to eligible people ages 18 years and up

    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 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

  • 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 UCSD UCSF

  • 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

  • Development of a Novel Biomarker for Liver Fibrosis

    open to eligible people ages 18 years and up

    The overall aim of this study is to validate a quantitative digital tool for staging liver fibrosis in biopsies from chronic human liver diseases and then evaluate it prospectively in patients.

    at UCLA

  • 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 UCSF UC Davis

  • 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 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

  • 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 Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

    Sorry, in progress, not accepting new patients

    Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

    at UCLA UCSF UC Davis

  • 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

  • Development of Kinetic Biomarkers of Liver Fibrosis Measuring NAFLD

    Sorry, not yet accepting patients

    This is a small preliminary study conducted to explore new methods for the potential of aiding in diagnosis of liver fibrotic disease as well as predicting disease progression. There will be a total of 4 visits spread out over approximately 8 weeks. You will be asked to drink "heavy water" during most of that time. "Heavy Water" also known as deuterated water, is physically and chemically very similar to ordinary drinking water. It tastes and feels exactly like regular water. It is odorless and has no known harmful effects at the doses given here. Heavy water occurs naturally, and is a minor component of the water we all ingest daily.

    at UCSD

  • 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

  • Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

    Sorry, in progress, not accepting new patients

    To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these subjects.

    at UCLA UC Davis

  • 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 Study Protocol

    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, in progress, not accepting new patients

    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

  • Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.

    at UCSF

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

    Sorry, not currently recruiting here

    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 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

  • Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults

    Sorry, not currently recruiting here

    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

  • 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

  • The EPIC Observational Study

    Sorry, in progress, not accepting new patients

    The purpose of this study is to better define risk factors preceding first isolation of Pseudomonas aeruginosa (Pa) from respiratory cultures in cystic fibrosis (CF) lung disease and to better define clinical outcomes associated with acquisition of Pa. This study will also collect and bank DNA samples for current and future studies designed to enhance the understanding of the pathogenesis of CF.

    at UCSF

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