Delivering clinical research june 2013.xlsx

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A long term monitoring study to evaluate the persistence of direct actingantiviral (DAA) treatment resistant mutations or the durability of sustainedvirological response (SVR) in patients treated with DAA containing regimensfor chronic hepatitis C infection (CHC) A MULTICENTER, PHASE III, OPEN-LABEL, RANDOMIZED STUDY IN PREVIOUSLYUNTREATED PATIENTS WITH ADVANCED INDOLENT NON-HODGKIN'SLYMPHOMA EVALUATING THE BENEFIT OF GA101 (RO5072759) PLUSCHEMOTHERAPY COMPARED WITH RITUXIMAB PLUS CHEMOTHERAPYFOLLOWED BY GA101 A Multi-Centre 3-Year Fol ow-Up study to Assess the Durability of SustainedVirologic Resonse in Alisporivir-Treated Chronic Hepatitis C Patients A new vaccine against meningitis groupB: A second fol ow on study A Phase 3 Evaluation of Daclatasvir in Combination with Peg-interferonLambda-1a and Ribavirin (RBV) or Telaprevir in Combination withPeginterferon Alfa-2a and RBV in Patients with Chronic Hepatitis C Genotype1b who are Treatment Naïve or Prior Relapsers to Alfa/RBV Therapy A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Nul or PartialResponders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligibleto P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis CGenotype 1b Infection A Phase 3, Randomised, Double-blind, Placebo-control ed, Paral el-group,Multi-centre Study to Evaluate the Safety and Efficacy of UstekinumabInduction Therapy in Participants with Moderately to Severely Active Crohn?sDisease A Phase 3, Randomised, Double-blind, Placebo-control ed, Paral el-group,Multi-centre Study to Evaluate the Safety and Efficacy of UstekinumabMaintenance Therapy in Subjects with Moderately to Severely Active Crohn'sDisease A phase III open-label randomised study, to evaluate the immunogenicity andsafety of the concomitant administration of V419 (PR5I) given at 2, 3 and 4months of age with two types of meningococcal serogroup C conjugate (MCC)vaccines given at 3 and 4 months of age, and fol owed by the administrationat 12 months of age of a combined Haemophilus influenzae type b-MCCvaccine.
A phase III randomised, partial y double-blind and placebo-control ed study ofBI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1hepatitis C infection in an extended population of treatment naïve patientsthat includes those ineligible to receive peginterferon.
A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLEDSTUDY OF VEMURAFENIBVERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks incombination with pegylated interferon-? (PegIFN) and ribavirin (RBV) inpatients with genotype 1 chronic hepatitis C infection who failed a priorPegIFN / RBV treatment A Phase III, Randomized, Comparative, Open-label Study of Intravenous IronIsomaltoside 1000 (Monofer?) Administered as Maintenance Therapy bySingle or Repeated Bolus Injections in Comparison with Intravenous IronSucrose in Subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy(CKD-5D).
A Phase l Study of Dasatinib Therapy in Children and Adolescents with Ph+Leukemia with Resistance of Inolerance to Imatinib Phase l/l study of Scr/ABityrosine kinase inhibitor dasatinib (BMS-354825) in children and adolescentswith relapsed or refractory leukemia A Proof of Concept Study for GSK249320 versus placebo in Stroke Patients A Randomised, Double Blind, Paral el Group, Multicentre Phase IIb study tocomplare ticagrelor with clopidogrel treatment on the risk of cardiovasculardeat, myocardial infarction and ischeamic stroke in patients with establishedPeripheral Artery Disease A randomized, control ed, open-label, paral el-group, multi-center study tocompare the effect of Intrathecal Baclofen Therapy (ITB Therapy?) versus BestMedical Treatment (BMT) on severe spasticity in post-stroke patients after 6months active treatment A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100(ASP9785) vs. Bicalutamide in Castrate Men with Metastatic Prostate Cancer 11/LO/0608 A study exploring the efficacy and safety of once-daily oral Rivaroxaban (BAY59-7939) compared with that of dose-adjusted oral vitamin K antagonist (VKA)for the prevention of cardiovascular events in subjects with nonvalvular atrialfibril ation scheduled for cardioversion Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab)versus placebo after complete resection of high-risk Stage III melanoma: Arandomized, double-blind Phase 3 trial of the EORTC Melanoma Group BIA-2093-311: Efficacy and safety of eslicarbazepine acetate (BIA 2-093) asmonotherapy for patients with newly diagnosed partial-onset seizures: Adouble-blind, randomized, active-control ed, paral el-group, multicenterclinical study Clinical Protocol AI444026: An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and MBS-790052 With or Without BMS-650032for subjects with Chronic Hepatitis C OVATION POST-MARKET STUDY Ovation Abdominal Stent Graft System Randomised, phase IV, placebo-control ed, comparative study to evaluate theefficacy and safety of tapering methotrexate (MTX) dosage versus maintainingthe dosage in patients with severe active Rheumatoid Arthritis (RA) who havedemonstrated an inadequate response to prior disease-modifying anti-rheumatic drugs (DMARDS) treatment and have initiated RoActemra®(Tocilizumab, TCZ) in combination with MTX.
Surgical replacement and transcatheter aortic valve implantation Zenith TX2 Low-Profile TAA Endovascular Graft Clinical Study #08-017-03 A Phase 3 Evaluation of BMS-790052 in Combination with Peg-Tnerferon Alfa-2a and Ribavirin in Treatment-Nainve Subjects with Chronic Hepatitis CGenotypes 1 and 4 A Phase 3, Multi-centre, Randomised, Double-blind, Placebo-control ed,Paral el-group study of the Efficacy and Safety of Lenalidomide (Revlimid?) asMaintenance Therapy for Patients with B-Cel Chronic Lymphocytic Leukaemiafol owing Second-line Therapy.
A Phase II single blind, randomized, placebo control ed trial to study theefficacy and safety of anti-von Wil ebrand factor Nanobody administered asadjunctive treatment to patients with acquired thrombotic thrombocytopenicpurpura.
A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab InPreviously Treated Subjects With CD20-Positive B Cel Non-Hodgkin?sLymphoma Who Are Ineligible For Or Have Previously Received An AutologousStem Cel Transplant A phase III, randomised, double-blind and placebo control ed study of oncedaily BI 201335, 240 mg for 12 or 24 weeks in combination with pegylated interferon-? and ribavirin in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN/RBV treatment A Randomized, Double-Blind, Multicenter Study of Denosumab ComparedWith Zoledronic Acid (Zometa?) in the Treatment of Bone Disease in Subjectswith Newly Diagnosed Multiple Myeloma An open Phase I Study of immunization with the recNY-ESO-1 + AS15 Antigen-Specific Cancer Immunotherapeutic in patients with NY-ESO-1-positiveunresectable and progressive metastatic cutaneous melanoma.
A multi-centre double-blind paral el-group placebo-control ed study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta Comparison of New Ostomy Barriers and Drainable Pouches to currently European Study of POBA versus Cotavance Paclitaxel Coated Bal oon for theTreatment of Infrapopliteal Lesions in Critical Limb Ischemia Randomized, Double-Blind, Control ed Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV) 13/LO/0425 study to assess the incidence of mutations in the tyrosine kinase domain of the epidermal growth factor receptor in UK patients with newly diagnosedlocal y advanced or metastatic non-smal cel lung cancer and to investigate the quality of life of these patients undergoing first-line monotherapy with A multi-center, randomized, paral el-group, rater-blinded study comparingthe effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis.
A multi-center, randomized, paral el-group, rater-blinded study comparingthe effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis.
A Phase 3, randomised, double-blind study of the safety and efficacy ofGSK1349572 plus abacavir/lamivudine fixed-dose combination therapyadministered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects.
A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics,Safety and Efficacy of BPL?s High Purity Factor X in the Treatment of Severe A phase III, open-label, multicentre study to evaluate the immunogenicity,safety and reactogenicity of revaccination dose of the GlaxoSmithKlineBiologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A,administered to children who previously participated in study 115345 (FLU D- A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED,DOSE-RANGING PHASE II STUDY ASSESSING RANOLAZINE IN THE MAINTENANCE OF SINUS RHYTHM AFTER ELECTRICAL CARDIOVERSION IN PATIENTS WITH NON-PERMANENT ATRIAL FIBRILLATION An Open-Label, Multicenter Extension Study to Evaluate the Safety andTolerability of Natalizumab Fol owing Re-Initiation of Dosing in Multiple Sclerosis Who Have Completed Studies C-1801, C-1802 and a Dosing Efficacy Study of a Quadrivalent Influenza Vaccine in Children (FLU D-QIV) Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Protocol RTA115450: A two part double blind, randomised, placebo-control ed and open-label study to investigate the efficacy, safety andtolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immume (idopathic) To prospectively col ect global 'real world' safety and clinical performance data on Endurant Stent Graft System. This is a registry only.
A double-blind, randomized, placebo-control ed Phase III study to assess theefficacy of MAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE- A3 positive resected stage III melanoma.
A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DOCETAXEL AND PREDNISONE WITH OR WITHOUT LENALIDOMIDE IN SUBJECTS WITH CASTRATE-RESISTANT PROSTATE CANCER (MAINSAIL) A Phase 3, Multicentre, Randomised, Open-Label, Paral el-Group Study of theEfficacy and Safety of Lenalidomide (Revlimid) Versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients with B-Cel Chronic Lymphocytic Leukaemia. (The Origin Trial) A Phase 3, Randomised, Double-blind, Placebo-control ed, Paral el-group,Multi-centre Study to Evaluate the Safety and Efficacy of UstekinumabInduction Therapy in Particiapnts with Moderately to Severely Active Crohn?s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety andEfficacy of GS 9350-boosted Atazanavir Versus Ritonavir-boosted AtazanavirEach Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults. (GS-US-216-0114) A Phase III Prospective, Two-cohort, Non-randomized, Multi-centre, Multi-national, Open Label Study to Assess the Safety of Assisted- and Self- administered Subcutaneous Trastuzumab as Adjuvant Therapy in Patients with Operable HER2-positive Early Breast Cancer A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICALTRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PERTUZUMAB +TRASTUZUMAB + DOCETAXEL vs. PLACEBO + TRASTUZUMAB + DOCETAXEL IN PREVIOUSLY UNTREATED HER2-POSITIVE METASTATIC BREAST CANCER A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer.
A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma A Randomized, Open-label, Phase 3 Study of Carfilzomib vs Best Supportive Care in Subjects with Relapsed and Refractory Multiple Myeloma An Open-Label, Multicenter, Fol ow-up Study to Evaluate the Long-TermSafety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Partial Onset Seizures An open-label, randomized, multi-center, Phase III study to compare thesafety and efficacy of TKI258 versus sorafenib in patients with metastaticrenal cel carcinoma after failure of antiangiogenic (VEGF-targeted and mTOR CIS Study: An international, Multi-centre, Randomised, Double-Blind, placebocontrol ed paral el group study to evaluate the efficacy and safety of two year treatment with Teriflunomide 7mg once daily and 14mg once daily versus the plaebo in patients with a first clinical episode suggestive of multiple sclerosis 07/H0707/112 CoreValve Advance International Post Market Study A Multi-centre, Interventional, Prospective, Post-Market Release Study Phase II randomised, placebo control ed trial to investigate repeat dose antimicrobial photodynamic therapy in patients with chronic venous leg TEMSO Extension: Long-term extension study of the multinational, double-blind, placebo control ed study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14mg) in patients with multiple A Phase III Randomized, Double-blind Study of the Safety and Efficacy ofGSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, BothAdministered with an Investigator-selected Background Regimen Over 48Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy- A Double-Blind, Randomized, Paral el Group, Multi-Centre Study to Evaluatethe Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjectswith Overactive Bladder (OAB) Treated with Antimuscarinics and Dissatisfied A multicentre, single arm study of Trastuzumab Emtasine (TDM-1) in HER2positive local y advanced or metastatic breast cancer patients who have received prior anti-HER2 and chemotherapy-based treatment.
A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain A Phase 3, Randomized, Double-Blind, Double-Dummy, Paral el Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176bVersus Warfarin In Subjects with Atrial Fibril ation – Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibril ation (ENGAGE – AF TIMI - 48) A Randomized, Double-Blind, Placebo-Control ed, Multicenter, Paral el-GroupStudy to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (=16 To 80 Years Old) With Partial Onset Seizures A single arm, open-label, multicenter study evaluating the long-term safety and tolerability of 0.5 mg fingolimod (FTY720) administered oral y once daily in patients with relapsing forms of multiple sclerosis ALTITUDE: A randomised, double-blind, placebo-control ed, paral el-groupstudy to determine whether, in patients with type 2 diabeted at high risk forcardiovascular and renal events, aliskiren, on top of conventional treatment, reduces cardiovascular and renal morbidity and mortality FINISH 3: A Phase 3, Randomised, Single Blind, Control ed Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis GWCA0962: A double blind, randomized, placebo-control ed, paral el groupstudy of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctivetherapy in relieving uncontrol ed persistent chronic pain in patients withadvanced cancer, who experience inadequate analgesia during optimized A ClinIcal EvaluatioN of ST Changes in a Group of PatIents havinG VentricularArrHyThmias A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 InfectedSubjects A phase II randomised, double-blind and placebo-control ed study of BI207127 in combination with faldaprevir and ribavirin in patients withmoderate hepatic impairment (Child-Pugh B) with genotype 1b chronichepatitis C infection B1971009 Phase 3 study to assess Meningococcal B Vaccine

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