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NCT ID: NCT01318694 Completed - Clinical trials for Hepatitis C, Chronic

Efficacy and Safety Study of DEB025/Alisporivir Combined to Peg-IFN and Ribavirin in Chronic Hepatitis C Genotype 1 Treatment-naïve Patients

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of Alisporivir when added to pegIFN and Ribavirin to optimize treatment in patient infected with the Hepatitis C virus who have not been previously treated for this condition

NCT ID: NCT01318486 Completed - Clinical trials for Chronic Kidney Disease

HepZero:Heparin Free Dialysis With Evodial

Start date: March 2011
Phase: N/A
Study type: Interventional

The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.

NCT ID: NCT01316406 Completed - Clinical trials for Palmar-Plantar Erythrodysesthesia Syndrome

Safety and Efficacy Placebo Controlled Study of ATH008 Cream in PPES Patients Secondary to Capecitabine

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy of ATH008 cream in patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy. In part I, the safety and plasmatic levels of the active ingredient and its metabolite will allow to determine the most appropriate and beneficial dose for the second part of the study. In Part II, the efficacy of ATH008 cream in reducing the number of patients presenting PPES grade 2/3 secondary to capecitabine therapy following a four times daily application will be tested.

NCT ID: NCT01316276 Completed - Cystic Fibrosis Clinical Trials

Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection

Start date: October 5, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.

NCT ID: NCT01316263 Completed - Clinical trials for Gastrointestinal Stromal Tumor (GIST)

A Study of IMC-3G3 in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the tumor response of stable disease (SD) partial response, or complete response (according to RECIST 1.1 criteria) at 12 weeks in patients with Gastrointestinal Stromal Tumors (GIST) harboring PDGFRα mutations and patients with GIST not harboring PDGFRα mutations.

NCT ID: NCT01315795 Completed - Clinical trials for Polycystic Liver Disease

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

LOCKCYST
Start date: March 2011
Phase: Phase 2/Phase 3
Study type: Interventional

An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.

NCT ID: NCT01315678 Completed - Clinical trials for Pseudomonas Aeruginosa Infection

Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections

Start date: February 29, 2012
Phase: Phase 3
Study type: Interventional

A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients. The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.

NCT ID: NCT01315613 Completed - Acute Pancreatitis Clinical Trials

Role of ST2 in Acute Pancreatitis

Start date: January 2005
Phase: N/A
Study type: Observational

Acute pancreatitis is characterized by an inflammatory storm which regulatory pathways are not well known. The IL-1 cytokine family is activated early during acute pancreatitis and secretion of alarmins is speculated during pancreatic necrosis. IL-33 is a member of the IL-1 family, it can act as an alarmin and its receptor, ST2, is known to sequester MyD88 which might regulate the acute pancreatitis inflammatory storm. The aim of this study is to investigate ST2 pathway in human acute pancreatitis and in murine experimental models of acute pancreatitis.

NCT ID: NCT01315249 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

ILLUMINATE
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

NCT ID: NCT01314716 Completed - Bronchiectasis Clinical Trials

Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

AIR-BX2
Start date: April 2011
Phase: Phase 3
Study type: Interventional

The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.