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Fibrosis clinical trials

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NCT ID: NCT01865812 Completed - Clinical trials for Primary Biliary Cirrhosis

Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

Start date: December 3, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).

NCT ID: NCT01863238 Completed - Cystic Fibrosis Clinical Trials

An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis

Start date: May 2013
Phase: N/A
Study type: Observational

This study is designed to evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of pediatric patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor treatment initiation and are receiving or planning to receive commercially-available ivacaftor in the US.

NCT ID: NCT01860872 Completed - Cystic Fibrosis Clinical Trials

Comparing Chest Images From MRI to CT in Patients With Cystic Fibrosis (CF)

Start date: April 2013
Phase:
Study type: Observational

The purpose of this research is to learn more about the heart and blood vessels in the lungs of people with cystic fibrosis (CF). This study will include approximately 36 children and adults with CF and 12 children and adults without CF. The study will involve one magnetic resonance imaging (MRI) . The research also includes blood samples to look at inflammation and lung tests called spirometry and Lung Clearance Index (LCI) determined by Multiple Breath Washout test. For the CF subjects, enrollment will be timed to coincide with routine scheduled computerized tomography (CT) or the CF subject may choose to have a CT for research purposes. The MRI will be compared to CT images of the lungs. The goal is to develop better imaging that does not use radiation.

NCT ID: NCT01859390 Completed - Cystic Fibrosis Clinical Trials

Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis

AquADEKs-2
Start date: June 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study will be to evaluate the effects of a modified formulation of AquADEKs (AquADEKs-2) on markers of inflammation, antioxidant levels and oxidative stress. Cystic Fibrosis (CF) is a disease that affects the organs in the body such as the lungs. Some of the damage to the lungs of CF patients may be caused by something called oxidant/antioxidant imbalance and oxidative stress. Oxidation in the body is kind of what happens to an apple when it turns brown after being cut. And, just as a squeeze of lemon juice stops the oxidation of an apple, antioxidants can stop the rusting (or damage) inside our bodies by unstable oxygen molecules called free radicals. Free radicals can help fight off bacteria and viruses but too many of them do damage instead. Our bodies need antioxidants to keep things in balance so we have the right amount of free radicals. Many CF patients also have trouble digesting food and absorbing nutrients like vitamins. Many of the vitamins we rely on are antioxidants, like vitamins A, D, E, K and beta-carotene. In some people with CF, even though they take multivitamins and pancreatic enzymes, they still have low amounts of antioxidants. We are looking to see if taking more vitamins and antioxidants will help CF patients. AquADEKs-2 is an investigational new drug (a drug that has not received approval by the Food and Drug Administration [FDA]). This research study is being done with the AquADEKs-2 compared to a control multivitamin. The study drug, AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K)that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium. The control multivitamin contains standard amounts of vitamins A, B, D, E, and K without additional antioxidant supplementation.

NCT ID: NCT01858519 Completed - Cystic Fibrosis Clinical Trials

Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy

Start date: August 2013
Phase:
Study type: Observational

This is a point prevalence study conducted entirely in the United States (US) to establish the prevalence of antibodies to hepatitis E virus (HEV) and other selected porcine viruses in cystic fibrosis (CF) patients receiving pancreatic enzyme replacement therapy (PERT) for pancreatic insufficiency compared with matched (age and region of residence) control patients with chronic medical conditions unexposed to PERT.

NCT ID: NCT01852942 Completed - HIV Infections Clinical Trials

Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV

Start date: September 2014
Phase: Phase 2
Study type: Interventional

This study was designed to test the hypothesis that treatment of HIV infected subjects with losartan, an agent with specific anti-inflammatory and anti-fibrotic actions, will: 1. reverse existing lymphoid tissue fibrosis, 2. restore lymphoid tissue architecture, 3. increase the number and improve the function of peripheral and lymphatic CD4 T cells, 4. decrease levels of systemic immune activation (IA), 5. decrease size of the HIV reservoir, and 6. be safe and well tolerated.

NCT ID: NCT01848392 Completed - Cystic Fibrosis Clinical Trials

Extrapulmonary Effects of Cystic Fibrosis on Physical Activity of Adult Patients.

MUCO-DAP
Start date: February 21, 2013
Phase: N/A
Study type: Observational

Physical activity seems to be a prognostic factor for quality of life and survival in patients with cystic fibrosis (CF). Whereas their exercise capacity has been assessed through medical examination, their daily physical activity has been little studied. Activity monitors have measured physical activity only in a few studies which considered mainly respiratory status and more recently bone mineral density and body composition. Determinants of physical activity in patients with CF remain largely unknown. The objective of this study is to measure daily physical activity with activity monitors in adult patients with CF and to investigate the determinants of physical activity, with a focus on extra-respiratory factors (nutritional status, diabetes, bone mineralization, anxiety and/or depression, cardiac impairment). Seventy adult patients with CF, regularly cared at the Cochin adult CF centre, will be recruited in a stable period during their annual review. During this assessment, laboratory tests will be carried out (especially parameters for nutritional status), as well as measurement of body composition and bone mineral density, respiratory function tests and a 6 minute walk test, and echocardiography. Patients will wear for 7 consecutive days a multi-sensor armband SenseWear on the arm, to assess the intensity of physical activity in metabolic equivalents (METS) and steps per day. Finally, patients will complete three self-administered questionnaires: Quality of Life (CFQ14 +), hospital anxiety depression scale and physical activity. After a descriptive analysis of the study cohort, we will study qualitative and quantitative criteria related to physical activity (assessed quantitatively by the number of steps/day or metabolic equivalents). Linear regression models will then be developed to assess the independent factors associated with physical activity, adjusting for different variables of interest related to patients demographic, behavioral, clinical (respiratory and non-respiratory ) and biological parameters. Conversely, the "predictive" independent aspect of physical activity will be studied according to respiratory function, nutritional status and quality of life.

NCT ID: NCT01844778 Completed - Cystic Fibrosis Clinical Trials

Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)

Start date: August 2013
Phase: Phase 4
Study type: Interventional

The purpose of this interventional Phase IV study was to explore the ease of use of TIP and prevalence of microbial contamination of the T-326 Inhaler compared with TIS and colistimethate administered via nebuliser for the treatment of Cystic Fibrosis (CF) patients chronically infected with P. aeruginosa. It was anticipated that the data from this study would provide clinicians with further guidance on the relative differences between the speed and ease of use of these treatments as well as useful information on the prevalence of microbial contamination of the inhalation devices in "real world" use.

NCT ID: NCT01842581 Completed - Cirrhosis Clinical Trials

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

Start date: January 8, 2013
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

NCT ID: NCT01840735 Completed - Cystic Fibrosis Clinical Trials

Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF

Start date: May 2013
Phase: Phase 1
Study type: Interventional

This study will determine the safety, tolerability, and pharmacokinetics of a single dose of GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.