The Pennine Acute Hospitals NHS Trust Performance in delivering clinical research Reporting period 1 October 2017 to 30 September 2018
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1 The Pennine Acute Hospitals NHS Trust Performance in delivering clinical research Reporting period 1 October 2017 to 30 September 2018 REC reference IRAS reference Name of trial Target number of? Minimum Maximum Target date to recruit? Date to recruit target Total recruited at target date Date the trial closed to recruitment Total study participants recruited Reason for closure of trial 15/LO/ Switching HIV-1 infected subjects with CNS toxicity from ATRIPLA to MK-1439A 16/EM/ A phase III, multicenter, randomized, doubleblind, double-dummy, active-controlled study comparing the efficacy and safety of gastric retentive, controlled release Accordion Pill Carbidopa/Levodopa (AP-CD/LD) to immediate release CD/LD 30/11/ /11/ Recruitment 30/06/ /12/ Withdrawn
2 17/NW/ A single arm, openlabel study to evaluate of Glecaprevir (GLE)/Pibrentasvir (PIB) in treatment naive adults with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis 16/EM/ An open-label, multicenter, follow-up study designed to evaluate the long-term effects of AP-CD/LD in fluctuating Parkinson's disease subjects who completed study IN /SW/ A randomized, doubleblind, placebocontrolled, parallelgroup, multicenter, event-driven Phase III study to investigate of finerenone, in addition to standard of care, on the progression of kidney disease 1 6 Date 4 4 Date 09/03/ /03/ Recruitment 31/03/ /12/ Withdrawn 08/06/ /06/ Recruitment
3 17/EM/ A phase III, randomized, multicenter, parallelgroup, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1- infected adults who are virologically suppressed 06/Q0703/ Phase IIIB, randomized, openlabel study of pegylated Interferon Alfa-2A monotherapy or in combination with Lamivudine compared with untreated control subjects in children with HBEAG-positive chronic hepatitis B in the immune-tolerant phase 17/EE/ A phase 2B, randomized, doubleblind, activecomparatorcontrolled, doseranging clinical trial to evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics 1 4 Date 3 3 Date 31/07/ /05/ Recruitment 30/09/ /03/ Withdrawn 24/04/ /04/ Recruitment
4 of MK-8591 given in combination with Doravirine (DOR) and Lamivudine 17/YH/ Paediatric use of the Abbott sensor based glucose monitoring system for 21 days - an accuracy evaluation 15/NE/ A phase 3, randomized, placebocontrolled, doubleblind study of oral Ixazomib maintenance therapy after initial therapy in with newly diagnosed multiple myeloma not treated with stem cell transplantation 15/SC/ A randomized, double blind, placebo controlled, parallel group, multi center, event driven Phase III study to investigate of finerenone on the reduction of cardiovascular morbidity and mortality in subjects with type 2 diabetes mellitus and the Date 1 2 Date 8 9 Date 15/06/ /06/ Recruitment 11/09/ /09/ Recruitment 30/09/ /09/ Recruitment
5 clinical diagnosis of early diabetic kidney disease in addition to standard of care 15/LO/ A phase 1, randomised, doubleblind, placebocontrolled, multicentre, ascending-dose trial to evaluate the safety, tolerability and immunogenicity of vaccine FP02.2 in HBeAg-negative hepatitis B as an add-on treatment to entecavir or tenofovir. 1 5 Date 31/10/ /10/ Recruitment
The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018
The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018 REC reference IRAS reference Name of trial First patient recruited?
Target date to recruit patients agreed? Target range minimum. Target range maximum. Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date No of patients recruited
Perfomance in Delivering (Commercial Trials)
Perfomance in Delivering (Commercial Trials) REC Ref IRAS ID Name of Trial Target Of? Minimum Of Maximum Of Target Date To Recruit? Total Date Of to recruit target number Recruited At of patients The Target
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Performance in Delivering Q4. Target number of patients
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Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July June 2013
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July 2012-30 June 2013 Name of trial Note, some study titles are shortened 1 Long-Term Study
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Integrated Research Application System Number. Total Number Of Study Participants Recruited. Research Ethics Committee Reference Number
Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial Minimum Number Of Patients Agreed Maximum Number Of Patients Agreed Date That The Trial Closed To
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October September 2013
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October 2012-30 September 2013 Research Ethics Committee reference number Name of Trial 1 12/NW/0321
Target date to recruit patients agreed? Target range. maximum. minimum. Date. 5 Agreed 26/01/ /11/2015 Recruitment Finished.
No REC Reference IRAS No Title Target number of agreed? Target range minimum Target range maximum Target date to recruit agreed? Planned Recruitment end date Total no of recruited at the agreed target
entecavir, 0.5mg and 1mg film-coated tablets and 0.05 mg/ml oral solution, Baraclude SMC No. (747/11) Bristol-Myers Squibb Pharmaceuticals Ltd
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Target date to recruit patients agreed? Target range minimum. Target range maximum
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date Total no of patients recruited
HRA Approval Date. confirmed by sponsor 07/04/ /04/ /04/ /04/ /04/ /04/ /05/2016
Reference Reason for delay in recruiting first 1 15/NE/0144 179243 AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN S DISEASE PREVIOUSLY ENROLLED
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Table 1 Salford Royal NHS Foundation Trust: Performance in initiating clinical research (HRA Approval) Reporting period 1 April March 2017
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Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April 2013-31 March 2014 Research Ethics Committee Name of Trial reference number 1 08/H0906/140
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.28 Subject: Olysio Pegasys Ribavirin Page: 1 of 7 Last Review Date: March 18, 2016 Olysio Pegasys
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.27 Subject: Olysio PegIntron Ribavirin Page: 1 of 7 Last Review Date: March 18, 2016 Olysio PegIntron
A - Nonconfirmation Suspended by Sponsor B - D - Date site. C - Closed ready to start. Permissions. Sponsor delays ied. delayed/den.
No REC Reference Number IRAS No Title Submission Type Valid Research Application Date of First Patient Recruitment Benchmark Met invited selected Approval date confirmed by sponsor confirmed A - Nonconfirmation
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents Visit the AIDSinfo website to access the most up-to-date guideline. Register for e-mail notification of guideline