Min Number of Patients Agreed. Target Date to Recruit Patients Agreed?

Transcription

1 NIHR 70 day Performance in Delivery Report Q REC IRAS Name of Trial Target of Patients Min of Patients Max of Patients Target Date to Recruit Patients? Date to Recruit Target of Patients Total of Patients Recruited at the Target Date Date the Trial Closed to Recruitment Total of Study Participants Recruited Reason for Closure of Trial 1 12/LO/ Safety and Performance study of the Edwards SAPIEN 3 Transcatheter Heart Valve 8 8 Date 15/07/ /07/ Recruitment 2 17/EM/ A Parallel Group, Double- Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Chronic Migraine 5 5 Date 06/07/ /07/ Recruitment 3 15/NE/ PROSPER: Prospective Real World Outcomes Study of Hepatic Encephalopathy Patients? Experience on Rifaximin-a (TARGAXAN?/XIFAXAN?) 5 5 Date 29/09/ /09/ Recruitment Page 1 of 21

2 550 mg 4 13/LO/ A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy SONAR: Study Of Diabetic Nephropathy with Atrasentan 6 6 Date 28/02/ /11/ Withdrawn By Sponsor 5 15/LO/ A phase I, randomised, double-blind, placebocontrolled, multi-centre, ascending-dose trial to evaluate the safety, tolerability and immunogenicity of Vaccine FP-02.2 in HBeAgnegative hepatitis B patients as an add-on treatment to entecavir or tenof 5 5 Date 15/08/ /08/ Recruitment 6 15/LO/ A Phase III Double-blind, Randomised, Parallel Group Comparison of the 4 4 Date 31/12/ /12/ Recruitment Page 2 of 21

3 Efficacy and Safety of FP lyo (Recombinant Human Interferon beta- 1a) and Placebo in the Treatment of Patients with Moderate or Severe Acute Respiratory Distress Syndrome 7 16/EE/ A PHASE IB, BLINDED, RANDOMIZED, MULTICENTER, MULTIPLE ASCENDING-DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF UTTR1147A ADMINISTERED TOPICALLY AND BY SUBCUTANEOUS INJECTION IN PATIENTS WITH NON HEALING NEUROPATHIC 3 5 Date 09/08/ /08/ Recruitment 8 15/LO/ Clinical and device functional assessment of real world ICD patients 6 6 Date 31/10/ /08/ Recruitment 9 16/LO/ PEPTIDE RECEPTOR RADIONUCLIDE THERAPY (PRRT) IN COMBINATION WITH LANREOTIDE 5 5 Date 25/07/ /07/ Recruitment Page 3 of 21

4 AUTOGEL: A RETROSPECTIVE STUDY IN PROGRESSIVE DIGESTIVE AND BRONCHOPULMONARY NEUROENDOCRINE TUMOURS /SW/ A Phase 2, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Tolerability of Entospletinib, a Selective SYK Inhibitor, in Combination with Systemic Corticosteroids as First-Line Therapy in Subjects with Chronic Graft Versu 1 3 Date 28/07/ /07/ Recruitment 11 16/EE/ Efficacy and safety of opicapone in clinical practice in Parkinson?s Disease patients with wearing-off motor fluctuations 4 4 Date 31/12/ /12/ Recruitment 12 15/NW/ A Feasibility Study of the ReGenerCell? Autologous Cell Harvesting Device for Diabetic Foot Ulcers 2 10 Date 21/07/ /07/ Recruitment Page 4 of 21

5 13 16/NW/ Phase 3, Randomized, Open-Label, Active- Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor- Na?ve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) 1 2 Date 06/07/ /07/ Recruitment 14 16/SS/ A prospective multi-centre observational cohort study assessing the effectiveness of Cortiment? for the treatment of mild-tomoderate active ulcerative colitis in routine clinical practice 5 8 Date 31/08/ /10/ Recruitment 15 16/NE/ A Randomized, Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir in Treatment-Na?ve or Treatment-Experienced Subjects with Genotype 1 and Genotype 3 Chronic Hepatit Date 11/09/ /09/ Recruitment Page 5 of 21

6 16 16/HRA/ Multicenter, Non- Interventional, Retrospective, Matched Cohort Study of Patients Monoinfected with Chronic Hepatitis B and with Moderate or Severe Renal Impairment Treated with Viread? or Baraclude? 5 5 Date 14/08/ /08/ Recruitment 17 14/LO/ A Phase II Proof of Concept (PoC), Double- Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects with Multiple Sclerosis 7 7 Date 28/07/ /07/ Recruitment 18 17/LO/ A Follow Up study to assess Resistance and Durability of Response to Abbvie Direct Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Date 14/08/ /08/ Recruitment Page 6 of 21

7 Hepatitis C Vi 19 17/NE/ An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Vo xilaprevir Fixed-Dose Combination for 12 Weeks in Subjects who Participated in a Prior Gilead-Sponsored HCV Treatment Study 1 1 Date 30/09/ /09/ Recruitment 20 13/LO/ Phase III Non-dialysis CKD 4 4 Date 10/07/ /08/ Recruitment 21 16/EE/ Safety and proof of principle study of ATX-GD- 59 in male and female subjects with Graves? disease not currently treated with anti-thyroid therapy: An Open label study, with an upward titration over five dose levels administered by Intradermal injection 1 3 Date 01/06/ /07/ Recruitment Page 7 of 21

8 22 16/LO/ Incidence and outcomes associated with the management of adenovirus infections in allogeneic hematopoietic cell transplant recipients: AdVance 1 5 Date 11/09/ /09/ Recruitment 23 13/NW/ A Phase 3, Randomized, DoubleBlind, PlaceboControlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukaemia in Complete Remission 5 5 Date 31/12/ /10/ Withdrawn By Sponsor 24 15/LO/ Phase 3 multi-center, outpatient, randomized, double-blind, placebocontrolled study of LY for the prevention of episodic cluster headache 2 2 Date 31/12/ /12/ Withdrawn By Sponsor 25 14/LO/ A Phase III Clinical Trial of Intra-arterial TheraSphere? in the Treatment of Patients with 2 4 Date 31/01/ /08/ Recruitment Page 8 of 21

9 Unresectable Hepatocellular Carcinoma (HCC) 26 15/EM/ A Phase 2, randomised, double-masked, shamcontrolled, multi-centre study to evaluate the efficacy and safety of ocriplasmin in inducing posterior vitreous detachment (PVD) in subjects with nonproliferative diabetic retinopathy (NPDR) (CIRCLE) 1 5 Date 31/12/ /12/ Recruitment 27 15/NW/ A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia 3 5 Date 08/11/ /10/ Withdrawn By Sponsor 28 16/LO/ A Phase 2a, Single-Blind, Randomized, Placebo- Controlled Study Evaluating the Safety, Anti-Viral Activity, and Pharmacokinetics of ARB- 4 4 Date 20/01/ /01/ Withdrawn By Sponsor Page 9 of 21

10 in Non-Cirrhotic, HBeAg-Negative and Positive Subjects with Chronic HBV Infection Receiving Nucleos(t)ide An 29 16/SC/ A RANDOMIZED, MULTICENTER, OPEN- LABEL, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF AZACITIDINE SUBCUTANEOUS IN COMBINATION WITH DURVALUMAB (MEDI4736) IN PREVIOUSLY NTREATED SUBJECTS WITH HIGHER- RISK MYELODYSPLASTIC SYNDROMES MDS) OR IN ELDERL 1 3 Date 15/07/ /10/ Recruitment 30 16/LO/ A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects with Previously Systemically Treated Advanced Hepatocellular Carcinoma 2 4 Date 06/03/ /02/ Recruitment Page 10 of 21

11 31 17/LO/ Clinical safety & efficacy of a new infant formula with specific medical purpose (FSMP) containing 2 human milk oligosaccharides (HMOs). 2 5 Date 28/02/ /02/ Withdrawn By Sponsor 32 16/LO/ A Phase III Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects with Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-240) 2 4 Date 30/09/ /11/ Recruitment 33 17/LO/ A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing- Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) 6 6 Date 31/03/ /03/ Withdrawn By Sponsor 34 16/LO/ A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator?s 1 3 Date 28/02/ /12/ Recruitment Page 11 of 21

12 Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia 35 17/LO/ CONSERVE: Coversin Long Term Safety and Efficacy Surveillance Study 2 2 Date 31/12/ /12/ Recruitment 36 17/SC/ A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching from Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25mg QD in Subjects with Chronic Hepatitis B who are Virologically Suppressed Date 31/10/ /10/ Recruitment 37 16/LO/ A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus Prednisolone Alone in 1 3 Date 30/08/ /12/ Recruitment Page 12 of 21

13 Subjects with Severe Alcoholic Hepatitis (AH) 38 17/WM/ A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke 1 5 Date 31/10/ /11/ Recruitment 39 16/YH/ RA : A MULTICENTER, OPEN- LABEL, UNCONTROLLED, EXTENSION STUDY OF RA IN SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO HAVE COMPLETED A RA CLINICAL STUDY 1 3 Date 15/11/ /11/ Recruitment 40 16/LO/ Non-interventional Study to Investigate the Short and Longterm Real-life Safety, Effectiveness, and Adherence of Velphoro? in Patients with hyperphosphataemia Undergoing Haemodialysis or Peritoneal Dialysis 1 10 Date 30/04/ /03/ Recruitment Page 13 of 21

14 41 12/NE/ An Open-Label, First-in- Human Study of the Safety, Tolerability, and Pharmacokinetics of VX- 970 in Combination with Either Gemcitabine or Cisplatin and Etoposide in Subjects with Advanced Solid Tumors 2 3 Date 11/09/ /09/ Recruitment 42 13/EE/ Revacept, an inhibitor of platelet adhesion in symptomatic carotid stenosis: a phase II, multicentre; randomised, dose-finding, double-blind and placebo-controlled superiority study with parallel groups Date 31/12/ /05/ Recruitment 43 13/LO/ A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Placebo in Previously Treated Subjects with Hepatocellular Carcinoma 4 4 Date 01/11/ /08/ Recruitment 44 14/EM/ A Phase 3, Open-Label, Randomized Study of Quizartinib (AC220) Monotherapy vs. Salvage 1 1 Date 01/09/ /09/ Recruitment Page 14 of 21

15 Chemotherapy in Subjects with FLT3-ITD Positive Acute Myeloid Leukemia (AML) Refractory to, or Relapsed after, First-Line Treatment with or without Hematopoietic S 45 14/NE/ A Phase 2b, Randomized, Double-Blind, Placebo- Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipientswith Respiratory Syncytial Virus (RSV) In 2 4 Date 21/09/ /09/ Recruitment 46 14/WS/ Multicenter, Randomized, Double-blind, Doubledummy, Activecomparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (E Date 20/09/ /09/ Recruitment Page 15 of 21

16 47 15/SS/ A Multi-national, Multicenter, Prospective, Randomized, Double Blinded, Placebocontrolled Trial to Evaluate the Efficacy of HyperBox Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers Date 31/12/ /02/ Recruitment 48 16/EM/ Global study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement to Optimize clinical outcomes Date 31/10/ /10/ Recruitment 49 16/LO/ DUOdopa in Patients with Advanced Parkinson's Disease (PD) - A GLobal OBservational Study Evaluating Long-Term Effectiveness (DUOGLOBE) Date 30/12/ /11/ Recruitment 50 16/LO/ Coversin Global Study: An Open-Label, Safety and Efficacy Trial in PNH Patients 1 1 Date 18/09/ /09/ Recruitment Page 16 of 21

17 51 16/LO/ A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination with Either Venetoclax or Placebo in Subjects with Relapsed or Refractory Multiple Myeloma Who are Sensitive or Na?ve to Proteasome Inhibitors. 2 4 Date 06/07/ /07/ Recruitment 52 16/SC/ A Phase 2 Randomised Double Blind Placebo controlled study evaluating the Safety, Tolerability and Efficacy of GS-9674 in Subjects with Primary Biliary Cholangitis without Cirrhosis 3 3 Date 30/11/ /03/ Recruitment 53 16/WM/ Phase 3, randomised, open-label, activecontrolled, parallel-group, multi-centre study to evaluate the safety and efficacy of GSK compared to recombinant human erythropoietin (rhepo) in dialysis subjects with anemia associated 4 6 Date 30/04/ /06/ Recruitment Page 17 of 21

18 with chronic kid 54 17/EM/ A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa- Treated Patients with Parkinson?s Disease Experiencing End of Dose?Wearing-Off? 2 2 Date 31/12/ /11/ Withdrawn By Sponsor 55 17/LO/ A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects with Chronic HCV Infection Who are on Dialysis for End Stage Renal Disease 1 3 Date 31/01/ /01/ Recruitment 56 17/LO/ A Double-Blind, Randomised, Placebo- Controlled, Parallel-Group, Phase 2, Dose Ranging Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral Litoxetine 10mg,20mg and 40mg Twice Daily (BID) 2 2 Date 04/06/ /05/ Recruitment Page 18 of 21

19 versus Placebo in Women with Mixed Urinary Incontin 57 17/LO/ A Multicenter, Parallel- Group, Randomized, Cross-Over Trial to Compare the Efficacy of LUMINITY? and SonoVue? in the Evaluation of Left Ventricular Endocardial Border Definition Date 31/05/ /03/ Recruitment 58 17/LO/ A Phase 3, Randomized, Double-Blind, Placebo- Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis 2 3 Date 19/08/ /04/ Recruitment 59 17/LO/ A Phase 3, Randomized, Double-Blind, Placebo- Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH) 2 3 Date 19/08/ /01/ Recruitment Page 19 of 21

20 60 17/LO/ A Phase 1b/2a, Dose- Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI- H0731 in Patients with Chronic Hepatitis B 5 5 Date 30/06/ /04/ Recruitment 61 17/LO/ An open label, single-arm, Phase I/II study of vandetanib-eluting radiopaque embolic beads (BTG ) in patients with hepatocellular carcinoma (HCC) without curative options. 3 6 Date 31/01/ /05/ Withdrawn By Sponsor 62 17/SC/ A Phase 1/2 Proof-of- Concept Study of the Combination of Acalabrutinib and Vistusertib in Subjects with Relapsed/Refractory B-cell Malignancies 2 4 Date 30/04/ /05/ Withdrawn By Sponsor 63 17/SC/ A Double-blind, Placebocontrolled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Date 31/05/ /05/ Recruitment Page 20 of 21

21 Oral Administration of XEN1101 in Healthy Male Subjects 64 Registry for Patients with Digital Ulcers Associated with Systemic Sclerosis (DU/SSc) Not Available / Not 16 19/11/ Recruitment Page 21 of 21