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NCT ID: NCT01240694 Terminated - Clinical trials for Systemic Lupus Erythematosus

A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus

Start date: December 9, 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).

NCT ID: NCT01237678 Terminated - Clinical trials for Small Cell Lung Cancer

A Study of IMGN901 for Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer

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

The purpose of this study is to test safety and efficacy of this combination treatment (IMGN901, carboplatin and etoposide) in patients with solid tumors and extensive stage small cell lung cancer.

NCT ID: NCT01232556 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

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

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

NCT ID: NCT01231555 Terminated - Clinical trials for Infection, Human Immunodeficiency Virus

Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET)

SIGNET
Start date: November 18, 2010
Phase: Phase 2
Study type: Interventional

This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background ART for all 3 arms will be chosen by the Investigators and will be either abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC] fixed dose combination (FDC) tablets. Antiviral activity, safety, PK, and development of viral resistance will be evaluated.

NCT ID: NCT01231347 Terminated - Cancer Clinical Trials

QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

GAMMA
Start date: April 2011
Phase: Phase 3
Study type: Interventional

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

NCT ID: NCT01229592 Terminated - Clinical trials for Catheter Related Infection

Ethanol in the Prevention of Central Venous Catheter Infections

Start date: December 2009
Phase: N/A
Study type: Interventional

In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success [1-10]. Long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique. Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs. Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU). Methods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).

NCT ID: NCT01228474 Terminated - Infertility Clinical Trials

Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme

Start date: October 2010
Phase: N/A
Study type: Interventional

Experimental study to assess the efficacy of single embryo transfer (SET) with respect to double embryo transfer (DET) in an oocyte donation programme, 160 recipients will be randomized in two groups

NCT ID: NCT01228266 Terminated - Multiple Sclerosis Clinical Trials

Mesenchymal Stem Cell Transplantation in MS

CMM-EM
Start date: December 2010
Phase: Phase 2
Study type: Interventional

The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis

NCT ID: NCT01226745 Terminated - Multiple Sclerosis Clinical Trials

A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis

DreaMS
Start date: October 2010
Phase: Phase 2
Study type: Interventional

The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in patients with relapsing-remitting multiple sclerosis (RRMS) in patients who have completed an initial 26-week study (ONO-4641POU006).

NCT ID: NCT01217814 Terminated - Clinical trials for Rheumatoid Arthritis

Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

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

Primary Objective: - Demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate [MTX] is superior in efficacy to placebo for the relief of signs and symptoms of Rheumatoid Arthritis [RA], in patients with active RA who have failed up to 2 Tumor Necrosis Factor α [TNF-α] antagonists. Secondary Objectives: - Assess the safety of sarilumab; - Document the pharmacokinetic profile of sarilumab.