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NCT ID: NCT01722487 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

Start date: March 2013
Phase: Phase 3
Study type: Interventional

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

NCT ID: NCT01721954 Completed - Clinical trials for Colorectal Cancer Metastatic

FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer

FOXFIREGlobal
Start date: May 1, 2013
Phase: Phase 3
Study type: Interventional

This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma. Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.

NCT ID: NCT01719263 Completed - Emphysema Clinical Trials

Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

Start date: June 2013
Phase: N/A
Study type: Interventional

This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.

NCT ID: NCT01716936 Completed - Clinical trials for Thoracic Insufficiency Syndrome

A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System

Start date: July 2012
Phase: N/A
Study type: Observational

The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.

NCT ID: NCT01715285 Completed - Prostate Neoplasms Clinical Trials

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

Start date: February 12, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

NCT ID: NCT01709578 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

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

Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is effective for: - reduction of signs and symptoms at Week 24 and - improvement of physical function at Week 12 in patients with active rheumatoid arthritis (RA) who are inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives are to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in patients with active RA who are inadequate responders or intolerant to TNF-α antagonists, for: - Reduction of signs and symptoms at 12 weeks. - Improvement in physical function at Week 24. - Improvement in disease activity score as measured by other American College of Rheumatology derived components at Weeks 12 and 24. - Improvement in quality of life as measured by patient reported outcomes (PROs) at intermediate visits and Week 24. To assess the safety of sarilumab in this population. To assess the exposure of sarilumab added to DMARD therapy in this population.

NCT ID: NCT01705977 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab Assessment of Safety in SLE

BASE
Start date: November 27, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

NCT ID: NCT01705704 Completed - Clinical trials for Hepatitis B, Chronic

A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B

Start date: June 2012
Phase: N/A
Study type: Observational

This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.

NCT ID: NCT01704404 Completed - COPD Clinical Trials

7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT01703000 Completed - Clinical trials for Coronary Artery Disease

NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions

Start date: November 2012
Phase: N/A
Study type: Interventional

NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of Atherosclerotic Lesion(s)