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NCT ID: NCT01056120 Completed - Clinical trials for De Novo and Re-stenosed Coronary Artery Lesions

Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice

ENERGY
Start date: March 2010
Phase: N/A
Study type: Observational

To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

NCT ID: NCT01055535 Completed - Clinical trials for Focal Vitreomacular Adhesion

Safety and Efficacy Study of Microplasmin in for Non-Surgical Treatment of Focal Vitreomacular Adhesion

MIVI-8
Start date: January 2010
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of Microplasmin administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal microplasmin may offer physicians a safe agent for pharmacologic vitreolysis and induction of Posterior Vitreous Detachment (PVD) without the need for vitrectomy. This clinical study is justified because the study sponsor believes the potential benefits outweigh the potential risks, as outlined below.

NCT ID: NCT01055496 Completed - Lymphoma, B-Cell Clinical Trials

Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma

Start date: March 2010
Phase: Phase 1
Study type: Interventional

This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

NCT ID: NCT01054625 Completed - Clinical trials for Head and Neck Cancer

Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Start date: March 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to support current and future Zalutumumab studies by increasing the Pharmacokinetic (PK) knowledge of the drug. PK is the study of how a drug is absorbed (taken up), distributed (moved around), metabolised (broken down) and excreted (removed) by the body, in relation to time. The first PK trial only went up to 8 mg/kg, and, as there has been some indication that the PK profile for the higher and lower doses is different, this needs to be further evaluated. Furthermore, there is a need for more PK data on dosing with 16mg/kg. The aim with this study is therefore to evaluate the PK profiles at different doses of Zalutumumab and the amount of drug in the blood at different time points after single and multiple doses. The results of this study, combined with data from completed and ongoing Zalutumumab studies, will enable us to provide patients with an effective treatment option which may significantly prolong their survival and/or improve their quality of life.

NCT ID: NCT01054573 Completed - Clinical trials for Hepatitis C, Chronic

VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

Start date: April 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

NCT ID: NCT01054014 Completed - Health Clinical Trials

A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and without food.

NCT ID: NCT01053715 Completed - Hemophilia A Clinical Trials

Quality of Life Study of Helixate NexGen

Start date: January 2010
Phase: N/A
Study type: Observational

The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.

NCT ID: NCT01052779 Completed - Anemia Clinical Trials

A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

FIRST
Start date: March 1, 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

NCT ID: NCT01052194 Completed - Clinical trials for Rheumatoid Arthritis

A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.

NCT ID: NCT01051622 Completed - Crohn's Disease Clinical Trials

PBMC (Peripheral Blood Mononuclear Cells) /Lymphocyte SPECT (Single Photon Emission Computerized Tomography) Imaging in Crohn's Disease

Start date: January 2010
Phase: Phase 1
Study type: Interventional

Using scintigraphic imaging including planar scintigraphy and SPECT, this study will evaluate the utility of two different ex vivo 99mTc-HMPAO labelled mononuclear cell populations in order to select the optimal methodology (using PBMC or purified lymphocyte subpopulations) for future drug intervention studies in Crohn's disease. Two parallel exploratory approaches will be investigated to enrich for lymphocyte populations expressing leukocyte trafficking inhibitors. In the first, whole blood will be fractionated on a ficoll gradient to purify a heterogeneous population of all the peripheral blood mononuclear cells (PBMC) for labelling. Secondly, further enrichment will be attempted using depletion of PBMC fractions of monocytes and B cells.