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Fibrosis clinical trials

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NCT ID: NCT00677092 Active, not recruiting - Clinical trials for Nephrogenic Systemic Fibrosis

Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis

GENESYF
Start date: May 2008
Phase: Phase 2
Study type: Interventional

- To determine the efficacy of imatinib mesylate in reducing cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). - To assess the safety and tolerability of imatinib mesylate in patients with chronic kidney disease and NSF.

NCT ID: NCT00440349 Active, not recruiting - Clinical trials for Retroperitoneal Fibrosis

Prednisone Versus Tamoxifen in Idiopathic Retroperitoneal Fibrosis

Start date: October 2000
Phase: Phase 2
Study type: Interventional

Idiopathic retroperitoneal fibrosis (IRF) is a rare disease characterised by the presence of a retroperitoneal periaortic fibro-inflammatory tissue which may entrap the ureters and cause renal failure. The treatment of IRF is not well established. Corticosteroids are frequently used, but the anti-estrogen agent tamoxifen has also been reported to be effective in a number of reports. However, no randomised trials have been published so far. The aim of the present study is to compare the efficacy of prednisone and tamoxifen in the treatment of IRF.

NCT ID: NCT00326482 Active, not recruiting - Liver Fibrosis Clinical Trials

Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy

Start date: July 31, 2006
Phase:
Study type: Observational

This study will provide a basis for research on the impact of liver injury caused by antiretroviral therapy in HIV-infected patients. Elevated liver enzymes called AST and ALT are common in HIV-infected patients taking antiretroviral medications and can indicate liver damage. Although there are a number of possible causes for these elevations, such as infections with a hepatitis virus, antiretroviral medications alone can lead to the elevations. The study will focus particularly on evidence of liver fibrosis, which is a sign of progressive liver damage. HIV-infected patients 18 and older who 1) have been taking combination antiretroviral therapy for at least 12 months and have been on a stable regimen for at least 3 months, and 2) have had elevated AST or ALT levels for at least 6 months may be eligible for this study. Patients who have had liver biopsies performed in the past may be eligible for participation. Participants undergo the following tests and procedures over a 12-month period: - Oral glucose tolerance test: The patient drinks a glucose (sugar) drink. Blood samples are then drawn over 2 hours through an intravenous (IV) line in the patient's arm. This test measures how high the patient's blood sugar and insulin levels rise after drinking a standard glucose load. - Transient elastography: This ultrasound test uses vibration (sound waves) to measure liver stiffness (fibrosis). Vibrations move faster through a fibrotic liver. - Triple-phase CT scan and single slice CT scan of L4-5: Patients fast for 4 hours before the CT scan. A contrast material is injected through a catheter placed in an arm vein to improve the visibility of the liver in the specialized X-ray images obtained in the CT scanner. - Liver biopsy: This test removes a small sample of liver tissue for microscopic examination, particularly for evidence of fibrosis. The skin over the biopsy site is numbed and a needle is passed through the skin and rapidly in and out of the liver. Patients may be given a sedative for the procedure. - Follow-up visits. Patients return for follow-up visits 1 to 4 weeks after the liver biopsy and three more times over the course of the study for a medical history, physical examination and blood tests. Patients may participate in an additional 4-year follow-up, during which they have visits every 3-12 months and are offered the opportunity to repeat the biopsy no sooner than 1 year after the first biopsy.

NCT ID: NCT00258544 Active, not recruiting - Pulmonary Fibrosis Clinical Trials

Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)

MAA
Start date: October 2001
Phase:
Study type: Observational

This study is investigating the way the lung is damaged in a condition called pulmonary fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy performed by the subject's surgeon. The identification of unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.

NCT ID: NCT00203697 Active, not recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Minocycline Therapy for Lung Scarring in Patients With Idiopathic Pulmonary Fibrosis - a Pilot Study

Start date: n/a
Phase: Phase 3
Study type: Interventional

Pulmonary fibrosis is essentially scarring in the lungs. Some types (DIP, NSIP) most often respond to therapy. Others like UIP (usual interstitial pneumonitis) rarely respond. UIP frequently progresses and has a poor prognosis with a survival of three to five years. In UIP, most often the cause cannot be determined and is therefore called Idiopathic Pulmonary Fibrosis (IPF). A prevalence rate of 27–29 cases/100,000 has been reported that may even be as high as 250 cases/100,000 in individuals 75 years of age. Idiopathic pulmonary fibrosis (IPF) is a chronic and fatal pulmonary disorder. Conventional treatment with immunosuppressive therapy has been disappointing, with a median survival of <40% at five years after diagnosis. Moreover, this therapy may lead to premature deaths that are a result of immunosuppression and susceptibility to infectious disease. Another problem related to IPF, is that we have an incomplete picture of the natural history of the pathogenesis of this disorder. Clearly, new strategies for therapy are necessary. Published evidence suggests that less than 20% of patients with IPF respond to corticosteroids (prednisone). In patients that fail steroids, immunosuppressant drugs such as azathioprine or cyclophosphamide are used. An international consensus statement recommends both steroids and azathioprine or cyclophosphamide from the onset of treatment. Unfortunately a large number of trials have shown little or no effect of these drugs on the progression of disease. There are currently no FDA approved drugs for the treatment of IPF. Laboratory findings establish that human specimens of Interstitial Lung Diseases including IPF demonstrate an impalance in expression of proteins (Th2 Cytokines, CC Chemokines, and CXC Chemokines). When these protein levels are in excess or low, they alter the normal lung mechanism, causing angiogenesis (abnormal blood vessel formation), inflammation, scar tissue formation and impaired immunity of the patient. We hope to establish that the efficacy of anti-angiogenetic agent as an add on therapy for IPF patients, will prove to bring stabilization or improvement. Minocycline has been shown to inhibit angiogenesis (new abnormal blood vessel formation) and thus affect the fibrotic process (prevent scar tissue formation). Laboratory and animal studies support a potential therapeutic role for Minocycline in IPF. Minocycline is a semi synthetic derivative of tetracycline. It was first marketed as an antibiotic in 1972. Clinical trials of minocycline have mainly been performed in sexually transmissible diseases and in acne. Minocycline is also used to treat several other diseases such as nocardiasis, mycobacteriosis, leprosy, lyme disease, pyoderma gangrenosum, autoimmune bullous dermatitis, carteaud disease, and prurigo. The usual side effects of minocycline are: lightheadedness, dizziness, or vertigo and pigmentation. We will investigate genetic, molecular, cellular, whole animal models, and human specimens from patients with fibrotic lung disease to test our prediction: The pathogenesis of pulmonary fibrosis (lung scarring) is due to “multiple hits” that causes an inbalance of certain mediators (proteins) that are responsible for abnormal blood vessel formation, scar tissue formation (with and without inflammation inside the lungs) and impaired immunity of the patient. Each of the 3 projects in this proposal have a direct link to other projects and clinical core. The SCOR clinical core will identify and enroll patients with Interstitial Lung diseases (ILD), including IPF. The clinical core will collect clinical data, as well as obtain fluids from lung washings and human lung tissue specimens. Each project will use human specimens as indicated in each of their specific aims to correlate their findings with response to therapy.

NCT ID: NCT00179413 Active, not recruiting - Cirrhosis Clinical Trials

Study of Long-Term Peg Intron Vs. Colchicine in Non-Responders.

Start date: January 2001
Phase: Phase 4
Study type: Interventional

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 Interferon/Rebetron/Peg Intron and have advanced fibrosis. The purpose of this study is to compare two treatments to slow down the progression of liver disease and to prevent liver failure and liver cancer. The treatment will not cure Hepatitis C, but is being evaluated to see if it can slow down disease progression.

NCT ID: NCT00148837 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis

Start date: September 2004
Phase: Phase 2
Study type: Interventional

Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.

NCT ID: NCT00037765 Active, not recruiting - Cystic Fibrosis Clinical Trials

Gene Modifiers of Cystic Fibrosis Lung Disease

Start date: September 2001
Phase:
Study type: Observational

The purpose of this study is to examine genetic modifiers of the severity of cystic fibrosis lung disease.

NCT ID: NCT00006273 Active, not recruiting - Cystic Fibrosis Clinical Trials

Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis

Start date: June 1996
Phase: N/A
Study type: Observational

OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in infants and children with moderate to severe cystic fibrosis versus age matched healthy controls. II. Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.

NCT ID: NCT00004315 Active, not recruiting - Cystic Fibrosis Clinical Trials

Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

Start date: November 1995
Phase: Phase 2
Study type: Interventional

OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.