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NCT ID: NCT01376310 Terminated - Cancer Clinical Trials

GSK1120212 Rollover Study

Start date: November 2, 2010
Phase: Phase 2
Study type: Interventional

This was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.

NCT ID: NCT01375127 Completed - Clinical trials for Kidney Transplantation

Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

Start date: August 2011
Phase: N/A
Study type: Observational

This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

NCT ID: NCT01375049 Completed - Cystic Fibrosis Clinical Trials

Aztreonam Lysine for Pseudomonas Infection Eradication Study

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

This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA. The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).

NCT ID: NCT01374906 Completed - Cushing's Disease Clinical Trials

Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

Start date: November 4, 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

NCT ID: NCT01374711 Completed - Sepsis Clinical Trials

The Effects of Immunostimulation With GM-CSF or IFN-y on Immunoparalysis Following Human Endotoxemia

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

The human body knows a biphasic immunological reaction to sepsis. First, the pro-inflammatory reaction takes place, marked by the release of pro-inflammatory cytokines like TNF-α, as a reaction to the bacterial toxins. Secondly, the counter regulatory anti-inflammatory reaction arises. This phase is acting as negative feedback on the inflammation by inhibition of the pro-inflammatory cytokines. This is called "immunoparalysis", a pronounced immunosuppressive state, which renders patients vulnerable to opportunistic infections. Most of the septic patients survive the initial pro-inflammatory phase, but die during this second stage.Research in the past has shown that immunostimulatory therapy with GM-CSF or IFN-γ has promising effects on the pro-inflammatory reaction during immunoparalysis ex vivo. Both drugs are known for their immunostimulatory effects. Recent pilot studies have showed in septic patients, that long-lasting monocyte deactivation in sepsis ex vivo can be reversed by these two immunostimulants. However, the mechanism and extent of immunoparalysis recovery may be different between the two compounds. Previously it has been shown that human endotoxemia (induced by LPS), leads to marked immunosuppression in healthy individuals, characterized by a transient refractory state to a subsequent LPS challenge (endotoxin tolerance). Consequently, human endotoxemia can serve as a standardized, controlled model for sepsis-induced immunoparalysis. Until now, all studies have focused on the ex vivo tolerance. However, we have recently proved, that the ex vivo condition is not completely representative for the in vivo situation. Ex vivo, leukocyte tolerance to LPS resolves within one day, while the in vivo immunoparalysis persists for two weeks. In this project, we will investigate the effects of both GM-CSF and IFN-γ in a parallel double-blind placebo controlled randomized manner on the immunoparalysis following human endotoxemia, both in-vitro and in vivo. As a result, we hope to get more insight in the pathophysiology of sepsis-induced immunoparalysis and thereby develop new immunostimulatory therapies that improve patient outcome

NCT ID: NCT01374503 Terminated - Healthy Volunteers Clinical Trials

First in Man Study of ALX-0651, a Nanobody Inhibiting CXCR4

Start date: June 2011
Phase: Phase 1
Study type: Interventional

The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers.

NCT ID: NCT01374451 Completed - Islet Cell Tumor Clinical Trials

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

COOPERATE-1
Start date: June 2011
Phase: Phase 2
Study type: Interventional

This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET

NCT ID: NCT01373684 Completed - Chronic Hepatitis B Clinical Trials

PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients

PAS
Start date: May 25, 2012
Phase: Phase 4
Study type: Interventional

This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.

NCT ID: NCT01373515 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia

Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label phase 1 feasibility and safety dose escalation study. The main objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML.

NCT ID: NCT01373151 Completed - Clinical trials for Rheumatoid Arthritis

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

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

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.