Performance in delivering Clinical Research at PHT Q3 14/15 study met the 70 day target study within 70 day target study not met 70 day target
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1 Performance in delivering Clinical Research at PHT Q3 14/15 study met the 70 day target study within 70 day target study not met 70 day target Research Ethics Committee 14/ES/0004 ALA-BCC-CT008 - A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of BF-200 ALA (Ameluz?) in comparison to Metvix? in the treatment of non-aggressive basal cell carcinoma (BCC) with photodynamic therapy (PDT) Available 6 Available 01/10/2019 Open Total recruited at site = 12 14/LO/0091 An observational cross-sectional study to describe the patient profile and secondary care management pathways for with hidradenitis suppurativa (HS) in the UK Available 10 Available 31/12/2014 Open Total recruited at site = 13; Timeline extended from the original date in contract of 31/12/2014 to 31/03/ /W/0612 A multicentre, randomised, double-blind, parallel group, placebo-controlled, phase III efficacy and safety study of benralizumab (MEDI-563) added to high-dose inhaled corticosteroid plus long-acting B2- agnoist in with uncontrolled asthma (SIROCCO) Available 1 Available 19/12/2014 Open Total recruited at site = 7; Study extended by sponsor from 19/12/14 to 13/02/15 12/WS/0305 A Prospective Randomized Comparison of the Biofreedom? Biolimus A9? Drug Coated Stent Versus the Gazelle? Bare Metal Stent in Patients at High Risk for Bleeding Available 15 Available 22/04/2014 Total recruited at site = 15; Sponsor extended recruitment period from Feb to 22/04/2014
2 13/W/0464 A Placebo-Controlled, Multicenter, Double-Blind, Randomized, Pharmacokinetic and Pharmacodynamic Trial of ID-6556 in Subjects with Acute-on-Chronic Liver Failure Available 3 Available 13/11/2014 Total recruited at site = 1; Extended timeline by sponsor 13/EE/0241 Secukinumab In with moderate to severe active, chronic plaque psoriasis who have failed on TFa antagoists: A clinical Trial EvalUating Treatment Results (SIGATURE) Available 2 Available 09/10/2014 Open Total recruited at site = 3; Timeline extended from the original date in contract 09/10/2014 to 31/12/2014 further to 31/03/ /EM/0414 A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis withpolyangiitis in Subjects Receiving Standard of Care Therapy. Available 2 Available 01/06/2014 Total recruited at site = 7 13/SC/0558 A 52-week, multicenter, randomized, double-blind, placebo-controlled study of subcutaneous secukinumab to demonstrate efficacy as assessed by palmoplantar pustulosis Psoriasis Area and Severity Index (pppasi) at 16 weeks of treatment, compared to placebo, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe chronic palmoplantar pustular psoriasis. Available 5 Available 12/12/2014 Total recruited at site = 7 13/EE/0276 A Phase 3B Randomized, Open-Label Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects with Genotype 2 or 3 Chronic HCV Infection Available 8 Available 31/05/2014 Total recruited at site = 13 13/EM/0348 Safety and Efficacy assessment of Monoprost? (unpreserved latanoprost) incomparison with Lumigan? 0.01 % and Lumigan? 0.03% UD, in with primaryopen angle glaucoma or ocular hypertension, stabilized by Lumigan? 0.01 % withocular surface intolerance. Available 6 Available 30/09/2014 Open Total recruited at site = 9; Extended clinical phase from Sept 2014 to Dec 2015
3 11/H/0140 LUMIOUS: Study to observe the effectiveness and safety of LUCETIS? through individualized patient treatment and associated outcomes" Available 100 Available 02/12/2014 Total recruited at site = /WM/0341 A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease Available 10 Available 31/03/2015 Open /A Total recruited at site = 8; Study extended by sponsor from 30/11/14 to 31/03/ /SW/0148 An Observational Post-Authorization Safety Study (PASS) of Victrelis? (boceprevir) among Chronic Hepatitis C (CHC) (P08518) Available 8 Available 01/07/2014 Total recruited at site = 10 11/LO/1921 A randomized, two-arm, open-label, multicenter Phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first line with HER2-positive and hormone receptor-positive advanced (metastatic or locally advanced) breast cancer. Available 3 Available 31/10/2014 Total recruited at site = 2 12/LO/1680 An observational study of avastin? (bevacizumab) as first line therapy in with advanced ovarian cancer Available 15 Available 31/03/2016 Open /A Total recruited at site = 10 12/WS/0300 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REG727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome Available 11 Available 01/03/2016 Open Total recruited at site = 14, maximum of 25 as oulined by sponsor in contract 13/LO/0528 An Open-label, Randomized, Controlled, Multicenter Study ExplorIng Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention Available 6 Available 01/12/2015 Open /A Total recruited at site = 1; Contract extended by sponsor
4 12/E/0361 An observational, non-interventional multi-center, multi-national study with Atypical Hemolytic-Uremic Syndrome (ahus Registry) Available 3 Available 01/06/2017 Open Total recruited at site = 3 13/LO/0549 A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of FG for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis Available 7 Available 30/10/2015 Open /A Total recruited at site = 2; Contract extended by sponsor 13/WA/0080 Observational Study Protocol IM101348ST LOG- TERM EXPERIECE WITH ABATACEPT SC I ROUTIE CLIICAL PRACTICE STUD ASCORE Available 6 Available 31/12/2015 Open /A Total recruited at site = 1 13/LO/0807 A Phase 2a, Randomized, Double-Blind, Placebo- Controlled, Multicenter, Parallel-Group Study of JJ ASH2001 in Syptomatic Adult Subjects with Uncontrolled, Persistent Asthma. Available 3 Available 31/10/2014 Total recruited at site = 7; Study extended by sponsor from 31/10/14 to 11/12/14 13/EM/0251 A multicenter, randomized, double-blind, placebocontrolled phase III study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure Available 20 Available 21/12/2015 Open /A Total recruited at site = 3 13/E/0345 LIVE:LIFE older heart failure Initiated on ivabradine in UK - quality of life Available 10 Available 31/03/2015 Open /A Total recruited at site =7; 30/06/2014 in contract but extended to 31/12/2014 and later to 31/03/2015 by sponsor 14/LO/0080 A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent on-hodgkin Lymphoma (ihl) Available 4 Available 30/06/2015 Open /A Total recruited at site = 2; Extended by sponsor from 01/12/2014 to 30/06/2015
5 14/EE/0035 Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase 3 Trial of Fulvestrant (Faslodex?) With or Without PD (Palbociclib)? Goserelin in Women with Hormone Receptor- Positive, HER2-egative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy Available 2 Available 31/07/2014 total recruited at site n = 1; revised target (5 to 2) and closure date (31/10/14 to 31/07/14) 14/WS/1055 An open-label study of inhaler device attributes investigating critical and overall errors, ease of use, and preference between a number of inhaler devices (ELLIPTA, TURBUHALER, HADIHALER, BREEZHALER, MDI, and DISKUS/ACCUHALER) in adult subjects with Chronic Obstructive Pulmonary Disease (COPD) Available 100 Available 02/03/2015 Open /A Total recruited at site = 12 14/WS/1017 The Impact of Rifaximin-a on the HS Hospital Resource Use Associated with the Management of Patients with Hepatic Encephalopathy: A Retrospective Observational Study (IMPRESS) Available 20 Available 25/11/2014 Total recruited at site = 20 14/WS/1001 A prospective, multicenter, open-label, centrally allocated, active-controlled,phase 2 study to evaluate the efficacy and safety ofmasitinib in combination with gemcitabine versus gemcitabinealone in advanced/metastatic epithelial ovarian cancer insecond line being refractory to first line platinum treatment or inthird line. Available 5 Available 28/02/2016 Open /A Total recruited at site = 1 14/LO/0087 An observational study on clearance on biologics in plaque psoriasis Available 10 Available 29/02/2016 Open /A Total recruited at site = 6
Date Agreed to recruit target number of patients available. Target number of patients. Available 100 Available 02/12/2014
Research Ethics Committee Reference umber ame of Trial Target number of patients available Target number of patients Date Agreed to recruit target number of patients available Date Agreed to recruit target
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