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Fibrosis clinical trials

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NCT ID: NCT00503490 Completed - Cystic Fibrosis Clinical Trials

Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis

Start date: June 2007
Phase: Phase 1
Study type: Interventional

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria.

NCT ID: NCT00499837 Completed - Cystic Fibrosis Clinical Trials

Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients

Start date: September 2007
Phase: Phase 2
Study type: Interventional

Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction, inflammation and destruction of the airways. The purpose of this study is to collect data about the resolution of the chronic inflammatory state in addition to assure the safety of the therapy in CF patients.

NCT ID: NCT00486837 Completed - Cystic Fibrosis Clinical Trials

Deposition of Inhaled Prolastin in Cystic Fibrosis Patients

CF2
Start date: December 2003
Phase: Phase 2
Study type: Interventional

The objective of this trial is to determine the optimal region of the lung for depositing Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF). The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either the deep lung or to the upper airways in a one to one randomization. The study will measure how much of the activity of the enzyme elastase is inhibited by AAT.

NCT ID: NCT00485082 Completed - Cystic Fibrosis Clinical Trials

Disclosing a Cystic Fibrosis Diagnosis to a Dating Partner

Start date: June 5, 2007
Phase: N/A
Study type: Observational

This study will examine the experience of disclosing a cystic fibrosis (CF) diagnosis to a dating partner. CF has implications for potential life partners (issues of fertility, decreased life span and an increasing need for medical management with age) that may make disclosure particularly sensitive. An understanding of the disclosure process may provide insight into ways health care practitioners can support their patients during this process. People between 21 and 35 years of age with CF who have been in at least one dating relationship may be eligible for this study. Participants are interviewed by telephone about their experiences living with cystic fibrosis and telling dating partners about their diagnosis. The interview includes questions about: - Past experiences disclosing their CF diagnosis to a dating partner - What information was disclosed versus what was not disclosed - Why certain information was disclosed or not disclosed - Positive and negative implications of the disclosure or non-disclosure The interview lasts about 60 minutes and is tape-recorded for later review and analysis.

NCT ID: NCT00483769 Completed - Cystic Fibrosis Clinical Trials

One Year Glargine Treatment in CFRD Children and Adolescents

Start date: February 2006
Phase: Phase 4
Study type: Interventional

Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements

NCT ID: NCT00476281 Completed - Diabetes Clinical Trials

Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

Start date: April 2008
Phase: N/A
Study type: Interventional

Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD implying that impaired glucose tolerance may be very early detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms and reduce complications. However, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. This device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. Previous studies of continuous glucose monitoring have been realized in CF patients with normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.

NCT ID: NCT00476060 Completed - Cirrhosis Clinical Trials

Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The standard treatment for decompensated cirrhosis is liver transplantation, however, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo-controlled trial in 50 patients with decompensated cirrhosis.

NCT ID: NCT00466336 Completed - Cirrhosis Clinical Trials

Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices

Start date: January 2003
Phase: N/A
Study type: Observational

The purpose of our prospective study was to evaluate the value of Doppler parameters and compare the diagnostic accuracy of Doppler parameters with various biochemical indices in predicting significant hepatic fibrosis (≥ F2) and cirrhosis (F4) in chronic hepatitis C (CHC) patients.

NCT ID: NCT00466271 Completed - Chronic Hepatitis C Clinical Trials

Prediction of Significant Hepatic Fibrosis in HCV Carriers With PNALT by SAPI- A Validation Study

Start date: April 2007
Phase: N/A
Study type: Observational

The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to receive combination therapy with pegylated interferon plus ribavirin and percutaneous liver biopsies.

NCT ID: NCT00463983 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide

FIBROSAND
Start date: October 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Octreotide is a somatostatin analog with a long half-life in vivo. Octreotide has interesting anti-inflammatory and anti-fibrotic properties in vitro and in vivo. Somatostatin receptors are increased and Octreotide uptake is increased in the lung in patients with idiopathic pulmonary fibrosis. Our hypothesis is that octreotide may slow the degradation of lung function in patients with IPF. In this proof of concept study, patients with IPF will receive an intramuscular injection of slow release octreotide (Sandostatin LP, 30 mg)every 4 weeks for 48 weeks. Lung function (FVC, DLCO), HRCT scores for fibrosis and ground glass, 6 minute walking test,quality of life and survival will be monitored.