integrated name of trial date of date of nhs first date of...

Research Ethics Committee Reference Number

Integrated Research Application System Number

Name of Trial Date of Receipt of Valid Research Application

Date of NHS Permission

First Patient Recruited?

Date of First Patient Recruited

Comments

14/EM/1306 161472 A Phase I/II, Open Label, Multicenter, Pilot Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacodynamics of FFP104 in Subjects Previously Diagnosed with Primary Biliary Cirrhosis (PBC)

15/06/2015 01/07/2015 No Potential subjects are still being contacted.

14/EM/0121 143800 RITUXILUP - An open label randomised multicentre controlled trial of RITUXImab and mycophenolate mofetil (MMF) without oral steroids for the treatment of LUPus nephritis

26/06/2015 02/07/2015 Yes 05/08/2015

14/WM/1143 160707 A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200 mg BID) for 10 days Compared with Fidaxomicin (200 mg BID) for 10 days for the Treatment of Clostridium difficile Infection (CDI)

08/06/2015 23/07/2015 No Contracts sent late, when sponsor did send contract, sent the wrong copies, therefore could not approve on

time. Study team seening patients but none are eligible

14/LO/2035 165898 APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALNTTR02) in Transthyretin (TTR)Mediated Polyneuropathy (Familial Amyloidotic PolyneuropathyFAP)

23/05/2015 27/07/2015 No Delay with harmonisation site receiving partially signed contract from CRO. 1 pt screened but not eligible

15/LO/0075 164748 A Phase 3 Multicentre, Double-Blind, Randomised, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA? or EPZICOM?/KIVEXA?, in Treatment-Naive HIV-1 Infected Subjects

13/07/2015 29/07/2015 Yes 06/08/2015

15/LO/0854 172710 A Phase III, randomised, multicentre, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-, NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed

27/07/2015 30/07/2015 Yes 21/09/2015

15/SS/0050 172724 A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary

07/08/2015 07/08/2015 Yes 07/10/2015

Arterial Hypertension

15/LO/1063 153501 M14-004 A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir (ABT450)/Paritaprevir (ABT267)/Ritonavir With and Without Dasabuvir (ABT 333) Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)

04/08/2015 11/08/2015 Yes 12/08/2015

14/NE/1100 152481 An open-label extension and safety monitoring study of moderate to severe ulcerative colitis patients previously enrolled in etrolizumab phase III studies

10/08/2015 11/08/2015 No No suitable patients

15/LO/0104 158474 Albumin To prevenT Infection in chronic liveR failurE (ATTIRE)

15/07/2015 14/08/2015 Yes 02/10/2015 Started screening on the 8th September but didn't have any patients till the 30/09/2015

14/SS/1087 164169 A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease.

12/08/2015 14/08/2015 Yes 24/09/2015

15/LO/0285 151828 Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and

03/08/2015 17/08/2015 No No subjects have been identified as yet. Meeting will be held to review

high risk of hospital mortality. strategy for recruitment

15/LO/0337 171675 A randomized, double-blind, placebo-controlled, prospective, multicenter, parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary hypertension

10/07/2015 26/08/2015 No Costings and contract delays

15/LO/0897 171318 A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF MPDL3280A (Anti PD-L1 ANTIBODY) IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATED ADVANCED RENAL CELL CARCINOMA

27/08/2015 27/08/2015 Yes 07/09/2015

13/SS/0051 123486 Targeted Rehabilitation to Improve Outcome after knee replacement- A Physiotherapy Study (TRIO-Physio)

01/07/2015 28/08/2015 Yes 08/10/2015 Costings and contract delays

15/LO/0743 179335 A phase 1, randomised, double-blind, placebo-controlled, multi-centre, ascending-dose trial to evaluate the safety, tolerability and immunogenicity of Vaccine FP-02.2 in HBeAg-negative hepatitis B patients as an add-on treatment to entecavir or tenofovir. HMR code: 15-501

19/08/2015 28/08/2015 No Several patients approached but none interested in participating (many due to high volume of study visits). Study centre aware.

15/NW/0437 157834 Pilot study to assess the effects of haemodialysis treatments on blood flow to the ear

07/09/2015 07/09/2015 Yes 07/09/2015

15/YH/0243 151920 A Phase 3, randomised, double-blind, placebo-Controlled study Investigating the efficacy and safety of multiple dupilumab dose regimens administered as monotherapy

13/08/2015 09/09/2015 No Patients seen but none recruited

for maintaining treatment response in patients with atopic dermatitis.

15/EE/0209 181562 Evaluation of Clinical Outcomes Following the use of SYSTANE HYDRATION inSubjects with Dry Eye

10/09/2015 10/09/2015 Yes 25/09/2015

15/LO/0689 178380 A Phase 3 Randomised, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of S-888711 (Lusutrombopag) for the Treatment of Thrombocytopenia in Patients with Chronic Liver Disease Undergoing Elective Invasive Procedures (L-PLUS 2)

14/09/2015 14/09/2015 Yes 04/11/2015

14/LO/2160 135564 Improving the detection of active tuberculosis (Tb) in accident and emergency (A&E) departments and evaluation of health protection service interventions against tuberculosis (The ACE Study).

21/05/2015 14/09/2015 No Delays in checks

15/LO/0881 177217 A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA? Once-Daily in Treatment-Na?ve HIV-1 Infected Subjects

14/09/2015 14/09/2015 Yes 06/10/2015

13/EM/0348 122371 Safety and Efficacy assessment of Monoprost? (unpreserved latanoprost) in comparison with Lumigan? 0.01 % and Lumigan? 0.03% UD, in patients with primary open angle glaucoma or ocular hypertension, stabilized by Lumigan? 0.01 % with ocular surface intolerance.

15/09/2015 15/09/2015 No This study is going ahead but the set-up has been complicated with the CRO leading to practical issues

of running the study which needed to be resolved resulting in a delay.

15/LO/1074 182401 A multi-centre, randomised, placebo controlled, double blinded, multiple dose trial investigating safety, pharmacokinetics and pharmacodynamics of concizumab administered subcutaneously to haemophilia A subjects

21/09/2015 21/09/2015 Yes 25/09/2015

14/LO/1193 151954 A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)

23/09/2015 24/09/2015 No Not activated yet

15/LO/1163 181430 A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects who are Virologically Suppressed on Regimens containing ABC/3TC

21/09/2015 24/09/2015 Yes 29/10/2015

15/NW/0505 177219 A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

23/09/2015 25/09/2015 Yes 07/10/2015

14/NW/1485 109922 A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in

17/11/2015 18/11/2015 No Delay in opening study due to delayed MHRA

Arteriovenous (AV) Access submission. Approvals now all in place . 19/04/16: Completed final preparations of grafts etc.

14/SC/1372 162784 RIVER - Research In Viral Eradication of HIV Reservoirs, A two-arm (proof of concept) randomised phase II trial

19/10/2015 25/11/2015 No Sponsor delay with contracts, was only signed off on the 20 November

15/LO/0073 150751 Sclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic sclerosis

18/03/2015 06/10/2015 No Sponsor (UCL) may have conducted some of the approval processes outside of harmonisation so Barts were waiting on Sponsor documentation that was not being uploaded. Also no patients consented yet

14/NE/1249 162695 A MULTISTAGE, PHASE II, STUDY EVALUATING THE SAFETY AND EFFICACY OF COBIMETINIB IN COMBINATION WITH PACLITAXEL AS FIRST-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST

30/09/2015 07/10/2015 No Small patient population/stringent eligibility criteria; have already pre-screened 3

CANCER patients

14/EE/1254 158807 A Phase III, multicentre,multinational randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma. Pilot Study

03/11/2015 04/11/2015 Yes 13/01/2016 Site activation delays

14/LO/0135 129217 A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-na?ve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)

10/11/2015 10/11/2015 Yes 05/04/2016 Commercial sponsor delays in activating site (2-3 months); 2 patients were missed in this period; continuing to pre-screen patients

14/SC/0171 120104 A phase III double-blind placebo-controlled randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.

03/11/2015 16/12/2015 No Activated in 1st week of Jan, delays by sponsor (contract sign off)

15/EE/0220 173810 Study into the effects of albumin replacement therapy on renal and circulatory function in patients implanted with the alfapump

12/11/2015 13/11/2015 Yes 10/02/2016 Non availability of nursing support for the study.

14/WM/0083 125950 A Phase III Trial of Surgery versus Active Monitoring for Low Risk Ductal Carcinoma in Situ (DCIS).

08/10/2015 09/10/2015 No Recruitment will take place at Edgware community hospital; time required to liaise with researchers

at ECH

14/SC/1030 155423 A randomised controlled trial to compare the clinical effectiveness and safety of gentamicin and ceftriaxone in the treatment of gonorrhoea.

17/08/2015 09/11/2015 No Checks completed within 1 day of the validation submission, contracts were misplaced preventing issuing of NHS Permission, also no patients consented

15/LO/1289 181953 An international, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial investigating the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures

20/10/2015 20/10/2015 No Patients not meeting criteria. Slightly less caseload due to bed issues and cancellation of elective cases.

15/LO/0051 154290 Improving continence in people with inflammatory bowel disease: active case finding and a randomised controlled trial

01/10/2015 12/10/2015 No

15/NE/0207 183792 PICTURE-Patient?Information?Combined?for?the?Assessment?of?Specific?Surgical Outcomes?in?Breast?Cancer

12/11/2015 12/11/2015 Yes 01/12/2015

15/LO/1239 184169 A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of

24/11/2015 27/11/2015 Yes 08/01/2016

darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once daily fixed dose combination regimen versus a regimen consisting of darunavir/cobicistat fixed dose combination coadministered with emtricitabine/tenofovir disoproxil fumarate fixed dose combination in antiretroviral treatment-na?ve human immunodeficiency virus type 1 infected subjects.

15/YH/0287 174975 An open label study of Dupilumab in patients with atopic dermatitis who participated in previous Dupilumab clinical trials.

05/11/2015 01/12/2015 Yes 09/12/2015

15/LO/1585 184835 A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for 24 Months to Adult Fabry Patients.

12/11/2015 12/11/2015 Yes 17/11/2015

15/NI/0127 184400 An Open-label Extension Study of Subcutaneously Administered ALN-AT3SC in Patients with Moderate or Severe Hemophilia A or B who have Participated in a Previous Clinical Study with ALN-AT3SC

17/12/2015 17/12/2015 Yes 12/01/2016

13/WS/0048 120377 Multicentre randomised trial of the effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence (OPAL-Optimal PFMT for Adherence Long-term)

27/10/2015 05/11/2015 Yes 26/11/2015

11/YH/0373 82708 Phase I/II study of oral MEK inhibitor 12/10/2015 06/11/2015 No No suitable

Selumetinib (AZD6244 Hyd-Sulphate) in Combination with Highly Active Anti-Retroviral Therapy (HAART) in AIDS-associated Kaposi?s sarcoma (KS).

patients

15/EM/0294 180267 A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients with an Infected Foot Ulcer

09/11/2015 24/11/2015 Yes 21/01/2016 No suitable patients

15/NW/0668 173723 A phase III, randomized, double-blind, placebo controlled multi-center study of subcutaenous secukinumab (150 mg and 300 mg) in prefilled syringe to demonstrate efficacy (including inhibition of structural damage), safety and tolerability up to 2 years in subjects with active psoriatic arthritis.

27/11/2015 16/12/2015 Yes 05/01/2016

15/EE/0355 187864 An Open-Label Study To Evaluate The Efficacy And Safety Of Revusiran In Patients With Transthyretin-Mediated Familial Amyloidotic Polyneuropathy With Disease Progression Post Orthotopic Liver Transplant

04/12/2015 07/12/2015 No First and only planned subject is coming tomorrow (26/04/16) for screening.

15/LO/1681 185104 A double blind, randomized, placebo-controlled trial evaluating efficacy and safety of oral nintedanib, 150 mg twice daily for 52 weeks (with follow up until last patient out up to a maximum of 2 years) in patients with ?Systemic Sclerosis associated interstitial lung disease?.

27/11/2015 08/12/2015 Yes 01/02/2016

15/LO/1244 183669 A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis (DcSSc)

30/11/2015 21/12/2015 Yes 09/02/2016 No patient Consented

15/LO/0217 163086 Effect of Remote Ischaemic Conditioning on clinical outcomes in ST-segment elevation myocardial infarction patients undergoing Primary Percutaneous Coronary Intervention (ERIC-PPCI): A multicentre randomised controlled clinical study

16/12/2015 21/12/2015 Yes 05/02/2016

13/YH/0394 138827 Multicentre Randomised Controlled Trial of Angiotensin Converting Enzyme inhibitor (ACEi) / Angiotensin Receptor Blocker (ARB) withdrawal in advanced renal disease; The STOPACEi Trial

10/03/2016 17/03/2016 Yes 12/05/2016

14/SS/1063 162472 Cattell Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy - a double blinded multicentred trial.

01/02/2016 16/02/2016 No

15/LO/1027 174615 A phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis ? a double-blind, placebo-controlled, randomized controlled trial

05/01/2016 11/01/2016 No Staff availability issues

15/EM/0188 163605 A randomized control trial of magnetic resonance imaging-targeted biopsy compared to standard trans-rectal ultrasound guided biopsy for the diagnosis of prostate cancer in men without prior biopsy

18/02/2016 19/02/2016 Yes 11/05/2016

15/LO/0676 177311 M116 - Feasibility and performances of 01/03/2016 03/03/2016 Yes 20/05/2016

spleen stiffness measurement as surrogate marker for esophageal varices in cirrhotic patients

15/WS/0128 168973 A Phase 1, first in man, multicenter, open label, single escalating dose study of BAY 1093884 in subjects with severe Hemophilia types A or B, with or without inhibitors

14/01/2016 03/02/2016 Yes 23/02/2016

15/NW/0108 165227 A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT

17/12/2015 13/01/2016 No Stringent inclusion criteria

15/LO/1824 180463 A feasibility study of Cardiac Output optimisation following Liver Transplantation (COLT trial)

05/02/2016 23/02/2016 Yes 23/04/2016

15/LO/1598 178793 A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

09/12/2015 08/01/2016 Yes 09/02/2016

13/NW/0496 115372 A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PAEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALISED TONIC-

08/03/2016 08/03/2016 No

CLONIC SEIZURES

15/ES/0115 183031 Open Label, Multinational, Multicenter, Real World Treatment Study of Single Agent AZD9291 for Patients with Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Prior Therapy with an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) - The ASTRIS Study

30/03/2016 30/03/2016 Yes 07/04/2016

15/SC/0431 179483 Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib

01/02/2016 01/02/2016 No

15/LO/1236 183416 A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis

08/02/2016 09/03/2016 Yes 15/05/2016 New HRA Process

15/LO/1592 184911 A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 mcg o.d.) vs tiotropium (18 mcg o.d.) + salmeterol/fluticasone propionate FDC

11/03/2016 17/03/2016 No

(50/500 mcg b.i.d.) in patients with moderate to severe COPD

15/LO/0710 177905 A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

03/02/2016 04/02/2016 No

15/LO/0638 176799 Paclitaxel assisted balloon Angioplasty of Venous stenosis in haEmodialysis access: The PAVE Trial. A multicentre double-blind randomised controlled trial in haemodialysis patients with a stenosis in a native arteriovenous fistula.

11/03/2016 18/03/2016 No

15/SS/0186 190856 A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) with and without Ribavirin (RBV) in Cirrhotic Subjects with Chronic HCV GT3 Infection.

29/01/2016 01/02/2016 Yes 09/02/2016

15/YH/0485 186367 A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel? (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis

25/02/2016 26/02/2016 Yes 19/05/2016

15/EE/0452 193802 A Phase 2a, Randomized, Double-blind, Placebo- and Naproxen-controlled, Parallel-group Study to Assess the

17/02/2016 07/03/2016 Yes 05/05/2016

Analgesic Efficacy of ASP7962 in Patients with Pain Due to Osteoarthritis of the Knee.

15/EM/0401 185662 TRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension

01/03/2016 04/03/2016 Yes 05/07/2016

15/NE/0374 186282 A multi-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and efficacy of LJN452 in patients with primary biliary cirrhosis

11/03/2016 17/03/2016 Yes 12/07/2016

16/LO/0022 195532 A Phase 1, Prospective, Open Label, Two Period, Fixed Sequence, Dose-Escalation Study of the PK and Safety of BAX 826 (PSA-rFVIII) in Previously Treated Patients with Severe (FVIII <1%) Hemophilia A

25/02/2016 25/02/2016 Yes 03/03/2016

16/LO/0036 195359 A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Na?ve Adults

23/03/2016 31/03/2016 Yes 18/04/2016

15/EE/0353 187464 A randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of the Bruton?s Tyrosine Kinase inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-

29/03/2016 29/03/2016 Yes 03/05/2016

paclitaxel and gemcitabine, in the first line treatment of patients with metastatic pancreatic adenocarcinoma

15/LO/2008 192214 A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Na?ve HIV-1 Infected Subjects with Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations.

01/03/2016 03/03/2016 Yes 07/04/2016

15/LO/2121 193977 Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching from ATRIPLA? (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Subjects

16/02/2016 04/03/2016 Yes 28/04/2016

15/LO/1952 192553 A placebo-controlled, double-blind, randomized trial to compare the effect of different doses of ALN-PCSSC given as single or multiple subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C.

01/03/2016 02/03/2016 Yes 22/03/2016

16/NS/0020 152874 A MULTICENTRE TRIAL COMPARING PATIENT SAFETY DURING INFRA RENAL AORTIC ANEURYSM REPAIR (EVAR) USING A NEW FULLY AUTOMATED AND ADAPTABLE CYDAR IMAGING GUIDANCE SOFTWARE TO HISTORICAL EXPERIENCE

12/02/2016 29/02/2016 Yes 02/03/2016

15/WA/0047 172127 A randomised, cross-over study to compare quality of life and satisfaction

26/02/2016 26/02/2016 Yes 04/04/2016

in primary immunodeficient patients treated with subcutaneous injections of Gammanorm? 165 mg/mL administered with two different delivery devices: injections using pump or rapid push

12/LO/1759 112232 A randomized controlled clinical trial to determine if a combined screening /treatment programme can prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies. Short Title ? ?Optimized TacrolimuS and MMF for HLA Antibodies after Renal Transplantation:? ? ?OuTSMART?

16/02/2016 18/02/2016 Yes 16/03/2016

14/NW/0055 130635 A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

02/02/2016 03/03/2016 No Delays with contracts

12/SS/0109 83251 International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)

29/03/2016 21/06/2016 No Awaiting SIV and New HRA Process

15/YH/0538 190662 A PHASE 3 STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF DUPILUMAB ADMINISTERED TO ADULT PATIENTS WITH SEVERE ATOPIC DERMATITIS WHO ARE NOT ADEQUATELY CONTROLLED WITH OR ARE INTOLERANT TO ORAL

28/03/2016 12/04/2016 Yes 27/04/2016

CYCLOSPORINE A, OR WHEN THIS TREATMENT IS NOT MEDICALLY ADVISABLE

11/LO/2019 76882 TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer.

29/03/2016 13/06/2016 No New HRA Process

16/LO/0290 190682 AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease

24/03/2016 07/04/2016 Yes 25/04/2016

16/SC/0041 193380 Integration of palliative care into the management of patients with advanced liver disease

09/06/2016 09/06/2016 No

10/H0604/51 43801 Natural history and pathogenesis of systemic IgG4 disease


15/SC/0682 186202 EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL? 120 MG ADMINISTERED EVERY 14 DAYS IN WELL DIFFERENTIATED, METASTATIC OR LOCALLY ADVANCED, UNRESECTABLE PANCREATIC OR MIDGUT NEUROENDOCRINE TUMOURS HAVING PROGRESSED RADIOLOGICALLY WHILE PREVIOUSLY TREATED WITH LANREOTIDE AUTOGEL? 120 MG ADMINISTERED EVERY 28 DAYS


16/NW/0022 193632 A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189).


15/LO/1044 173496 Adjuvant chemotherapy with 20/04/2016 10/06/2016 No New HRA

gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) A randomized, multidisciplinary, multinational AIO/DGAV/DGVS phase III trial.

Process

16/LO/0019 180161 Bone Evaluation in women over 40 who Switch from Truvada/NNRTI to Triumeq

23/03/2016 29/06/2016 No New HRA Process and awaiting SIV

15/YH/0117 173811 A prospective, multicenter, single-arm, open-label, Phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging

12/04/2016 14/04/2016 No Awaiting SIV

15/LO/2120 193745 Phase 3, prospective, randomized, multi-center clinical study comparing the safety and efficacy of BAX 855 following PK-guided prophylaxis targeting two different FVIII trough levels in subjects with severe Hemophilia A


16/SC/0089 196789 pRotective vEntilation with ven-venouS lung assisT in respiratory failure


15/NI/0137 181060 A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BLU-554 in Patients with Hepatocellular Carcinoma and Cholangiocarcinoma.


15/SC/0409 183061 Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration

29/03/2016 28/04/2016 No Awaiting SIV

15/SS/0171 177936 A Multi-national, Multi-center, Prospective, Randomized, Double Blinded, Placebo-controlled Trial to Evaluate the Efficacy of HyperBox Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers

21/03/2016 05/04/2016 No

13/EE/0214 128290 A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Risistance Patterns of Subjects with Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial.

30/03/2016 19/04/2016 Yes 06/06/2016

11/SS/0100 84669 A multicentre randomised trial to establish the effect(s) of routine administration of Fluoxetine for six months in patients with a recent stroke

02/03/2016 16/05/2016 Yes 27/05/2016 New HRA Process

15/SC/0103 154496 A multi-centre randomised study of induction chemotherapy followed by capecitabine (+/-nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer


16/LO/0762 195883 The feasibility of a structured, individualised exercise training programme for patients with cirrhotic liver disease awaiting transplantation surgery

09/05/2016 09/05/2016 Yes 19/05/2016

13/NW/0134 105317 Phase II randomised placebo controlled NEOadjuvant chemotherapy study of Nintedanib with Gemcitabine and Cisplatin in locally advanced muscle invasive BLADder cancEr

29/03/2016 26/04/2016 No

16/LO/0026 195795 A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Boosted Atazanavir or Darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

23/03/2016 22/04/2016 Yes 10/05/2016

16/LO/0596 193482 Adapting text message appointment reminders to improve attendance at diabetic retinopathy screening

18/04/2016 18/04/2016 No Awaiting SIV

Research Ethics Committee Reference Number

Integrated Research Application System Number

Submission Type

Name of Trial First Patient Recruited?

Date Site Selected

HRA Approval Date

Date Site Confirmed By Sponsor

Date Site Confirmed

15/LO/1812 190810 HRA Approval

Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients

No 16/05/2016 16/05/2016 24/05/2016 22/06/2016

Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism

integrated name of trial date of date of nhs first date of...

Documents