Row No.
1
2
3
4
5
Research
Ethics
Committee
Reference
Number
12/NW/0641
11/EE/0210
12/YH/0522
12/LO/1966
12/LO/1950
Integrated
Research
Application
System
Number
Name of Trial
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Reason For
Closure Of
Trial
Comments
Sponsor recruitment closure: This trial
closed to recruitment early because the
Sponsor cut the sample size drastically.
108307
A Phase III, Randomised, Double-Blind,
Placebo-Controlled Study of Vemurafenib
(RO5185426) Adjuvant Therapy in Patients
Range Agreed
With Surgically Resected, Cutaneous BRAFMutant Melanoma at High Risk for
Recurrence
8
10
Date Agreed
17/06/2015
4
17/06/2015
Recruitment
Finished
78485
A Randomized, Double-Blind, PlaceboControlled, Phase 2 Study to Evaluate the
Safety and Efficacy of CCX168 in Subjects
with Anti-Neutrophil Cytoplasmic
Number Agreed
Antibody (ANCA)-Associated Vasculitis on
Background Cyclophosphamide or
RituximabTreatment (Title chang
2
2
Date Agreed
31/12/2015
2
06/08/2015
Recruitment
Finished
110425
PROMISE - Prospective, Randomised Study
of Multicolumn Implantable Lead
Number Agreed
Stimulation for Predominant Low Back
Pain
31/08/2015
Recruitment
Finished
25
25
Date Agreed
31/08/2015
10
Sponsor halt and subsequent closure:
Target missed due to halt to recruitment
for six months during recruitment period
for safety reasons.
114803
A Phase 3, Randomized,
Placebocontrolled, Parallelgroup,
Multicenter, Doubleblind Study to
Evaluate the Efficacy and Safety of
Telotristat Etiprate (LX1606) in Patients
with Carcinoid Syndrome Refractory to
Somatostatin Analog (SSA) Therapy
Number Agreed
3
3
Date Agreed
30/05/2015
0
30/05/2015
Strict eligibility criteria: There were very
few participants that met the overall
criteria and the Sponsor has been having
difficulty with recruitment across
Recruitment European sites, overall. Recruitment has
Finished
been focused on the US where because of
various factors ie private health care there
is more disparity in medication the
patients receive and far more patients
met inclusion criteria.
117042
A Randomized, Open-label, Phase 3 Trial
of A+AVD Versus ABVD as Frontline
Number Agreed
Therapy in Patients With Advanced
Classical Hodgkin Lymphoma
5
5
Date Agreed
27/11/2019
12
03/09/2015
Recruitment
Finished
Row No.
6
7
8
Research
Ethics
Committee
Reference
Number
13/LO/0105
13/LO/0219
13/SC/0323
Integrated
Research
Application
System
Number
Name of Trial
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Reason For
Closure Of
Trial
Comments
06/04/2015
Recruitment
Finished
Recruitment has been difficult globally
due to tight inclusion/exclusion criteria.
We have continued to look actively for
suitable patients.The study closed to new
patients on the 6th April 2015. This is a
Sponsor decision. One patient was
recruited and completed the study and 6
patients were pre-screened who were not
eligible
119181
Open-label, single-arm, phase IV, multicentre trial to explore the immunogenicity
of the liquid formulation of Saizen in
Number Agreed
subjects with growth hormone deficiency
(GHD) of adult onset
120842
A Phase 2, Randomized, DoubleBlind,
PlaceboControlled, MultiCenter Study to
Assess the Efficacy and Safety of GS6624 Number Agreed
in Subjects with Idiopathic Pulmonary
Fibrosis (RAINIER)
3
3
Date Agreed
31/07/2014
0
20/07/2015
Strict eligibility criteria and early Sponsor
closure: 165 patients have been prescreened for this trial. Only 6 were
Recruitment
eligible for screening. One of the criteria is
Finished
a scan result and most patients fail on
this. The trial was then closed out early,
due to completed global recruitment.
131052
A Randomized, Double-blind, Placebocontrolled Phase 3 Study of the Bruton's
Tyrosine Kinase (BTK) Inhibitor, PCI-32765
(Ibrutinib), in Combination with
Number Agreed
Rituximab, Cyclophosphamide,
Doxorubicin, Vincristine, and Prednisone
(R-CHOP) in Subjects With Newly
5
5
Date Agreed
30/09/2020
5
28/08/2015
Recruitment
Finished
Range Agreed
3
7
Date Agreed
05/07/2015
2
22/12/2015
Withdrawn By
Host
Range Agreed
20
45
Date Agreed
31/07/2015
28
08/05/2015
Recruitment
Finished
9
13/SC/0503
133229
A Phase 1B open-label three-arm multicenter study to assess the safety and
tolerability of PF-05212384 (PI3K/mTOR
inhibitor) in combination with other antitumor agents
10
13/SC/0085
138492
EWOLUTION REgistry on WATCHMAN
Outcomes in RealLife Utilization
4
4
Date Agreed
15/07/2015
1
Closed to recruitment: Due to difficulties
caused by the Sponsor's management of
the system for trial slot allocation, this
Trust withdrew from further participation
as a site.
Row No.
Research
Ethics
Committee
Reference
Number
Integrated
Research
Application
System
Number
11
13/EE/0367
138166
12
14/EM/0142
149170
13
14
15
14/LO/0036
14/SC/0134
14/EE/0102
Name of Trial
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
A phase II, multicenter, randomized,
doubleblind, multiple dose,
placebocontrolled, parallelgroup study to
evaluate the efficacy, pharmacokinetics, Number Agreed
and safety of BI 655066, an IL23 p19
antagonist monoclonal antibody, in
patients with moderately to severely
Study MEA117113: Mepolizumab vs.
Placebo as addon treatment for
frequently exacerbating COPD patients
characterized by eosinophil level.
Number Agreed
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Reason For
Closure Of
Trial
Comments
3
3
Date Agreed
30/09/2015
3
28/08/2015
Recruitment
Finished
6
6
Date Agreed
31/08/2015
4
17/07/2015
Strict eligibility criteria: insufficient
Recruitment numbers of patients meeting the eligibility
Finished
criteria were seen. Most patients in
hospital were too severe.
07/07/2015
Rare patient group and terminated early:
This is a very rare patient group, with only
Withdrawn By
1 - 3 patients see each year. The total
Sponsor
recruitment target was only 3 over a
period of 2 years and the trial was
terminated 6 months early.
Insufficient eligible patients: Six patients
were screened for this trial, but none
found to be eligible. The Sponsor has now
closed the study early as global
recruitment was reached early at other
sites, so unable to achieve the target
recruitment.
134228
A Phase 3, Randomized, Open Label Study
Investigating the Efficacy of the BiTE
Antibody Blinatumomab Versus Standard
of Care Chemotherapy in Adult Subjects Number Agreed
With Relapsed/Refractory B precursor
Acute Lymphoblastic Leukemia (ALL)
(TOWER Study)
145143
AN OPEN-LABEL, MULTI-CENTER, DOSE
ESCALATION, PHASE I STUDY WITH AN
EXPANSION PHASE TO EVALUATE SAFETY,
PHARMACOKINETICS AND THERAPEUTIC
Number Agreed
ACTIVITY OF RO6895882, AN
IMMUNOCYTOKINE, CONSISTING OF A
VARIANT OF INTERLEUKIN-2 (iIL-2v)
TARGETING CARCINOEMBRYONIC
8
8
Date Agreed
30/09/2015
0
01/06/2015
Recruitment
Finished
149126
A prospective, randomized, open label,
blinded endpoint evaluation (PROBE)
parallel group study comparing edoxaban
(DU-176b) with enoxaparin/warfarin
Number Agreed
followed by warfarin alone in subjects
undergoing planned electrical
cardioversion of nonvalvular atrial f
9
9
Date Agreed
31/10/2015
12
28/10/2015
Recruitment
Finished
5
5
Date Agreed
31/01/2016
0
Row No.
16
17
18
19
Research
Ethics
Committee
Reference
Number
14/LO/0604
13/EM/0423
13/LO/1616
10/H0604/47
Integrated
Research
Application
System
Number
144196
142216
Name of Trial
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
A Phase III Randomized, Placebocontrolled Clinical Trial to Evaluate the
Safety and Efficacy of MK -8228
(Letermovir) for the Prevention of
Number Agreed
Clinically Significant Human
Cytomegalovirus (CMV) Infection in Adult,
CMV- Seropositive Allogeneic
Hematopoietic
A randomised, double blind, placebo
controlled, parallel group, dose ranging
study of GWP42004 as add on to
metformin in the treatment of
participants with Type 2 diabetes
Number Agreed
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Reason For
Closure Of
Trial
Comments
10
10
Date Agreed
31/08/2016
2
30/12/2015
Strict eligibility criteria: The protocol for
this trial is demanding it its eligibility
criteria. For example, the first potential
patient declined due to the requirement
that she agree to use two modes of
Recruitment
contraception. In addition to this, the
Finished
patient transplant population is only 1 in
70,000, so the group from which potential
patients can be identified is small. Two
patients have been consented, one was a
screen failure and one withdrew part way
through the trial.
6
6
Date Agreed
31/12/2015
8
29/09/2015
Recruitment
Finished
137039
A Phase 1/2 Study to Evaluate the Safety,
Tolerability, and Pharmacokinetics of
Number Agreed
MEDI4736 in Subjects with Advanced Solid
Tumors
5
5
Date Agreed
31/08/2015
4
31/08/2015
Sponsor delay: This is a slot driven trial
and it requires a suitable patient to be
available when a new slot is opened for a
new cohort.The delay in recruiting the
first patient on day 79 was entirely due to
Recruitment
the Sponsor not opening the 'slots' for
Finished
recruitment to the arm of the trial in
which this site had agreed to participate.
(Phase 1 trial). The only slots available for
the later cohorts are for groups into which
this site will not recruit.
48202
A phase 1, open label, dose finding study
to assess the safety and tolerability of
IMCgp100, a monoclonal T cell receptor Number Agreed
anti-CD3 scFv fusion protein in patients
with advanced malignant melanoma
10
10
Date Agreed
31/08/2013
35
29/01/2016
Recruitment
Finished
Row No.
20
21
Research
Ethics
Committee
Reference
Number
10/H0715/57
11/LO/1164
Integrated
Research
Application
System
Number
Name of Trial
60505
PREVAIL: A Multinational Phase 3,
Randomized, DoubleBlind, Placebo
Controlled Efficacy and Safety Study of
Oral MDV3100 in Chemotherapy Naive
Patients with Progressive Metastatic
Prostate Cancer Who Have Failed
Androgen Deprivation Therapy.
82065
22
12/NW/0311
101757
23
12/NE/0314
110919
24
12/WM/0039
96453
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Number Agreed
A RANDOMIZED, OPEN-LABEL,
MULTICENTER TRIAL TO DETERMINE
SAFETY AND EFFICACY OF ECULIZUMAB IN
THE PREVENTION OF ANTIBODY
Number Agreed
MEDIATED REJECTION (AMR) IN LIVING
DONOR KIDNEY TRANSPLANT RECIPIENTS
REQUIRING DESENSITIZATION THERAPY.
A phase III, randomised, observerblind,
placebocontrolled,multicentre, clinical
trial to assess the prophylactic, efficacy,
safety, and immunogenicity of GSK
Biologicals' herpes zoster gE/AS01b
candidate vaccine when, administered
intramuscularly on a twod
Range Agreed
Safety, Efficacy and Pharmacokinetics of
NNC-0156-0000-0009 in Previously
Number Agreed
Treated Children With Haemophilia B
(Paradigm 5)
INOVATEHF: Increase Of Vagal Tone in
Chronic Heart Failure. A pivotal trial to
Number Agreed
establish the longterm safety and efficacy
of the cardiofit system.
6
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
6
Date Agreed
08/04/2015
8
Reason For
Closure Of
Trial
08/04/2015
Recruitment
Finished
Strict Eligibility Criteria: Several patients
were consented and screened but only
one was enrolled and is still in long term
follow-up.
Original target was 5 by 31/12/2013 but
has been increased after agreement with
the sponsor.
10
10
Date Agreed
30/06/2014
1
27/04/2015
Recruitment
Finished
10
20
Date Agreed
30/11/2015
14
30/11/2015
Recruitment
Finished
1
1
Date Agreed
28/02/2013
1
06/01/2015
Recruitment
Finished
21/08/2015
Recruitment
Finished
10
10
Date Agreed
01/09/2014
11
Comments
Study team have recruited the original
target and have negotiatedto have the
target increased and an extension to the
time.
Row No.
25
26
27
28
29
Research
Ethics
Committee
Reference
Number
13/SC/0027
14/NW/1084
14/LO/1356
14/LO/1490
14/EM/1200
Integrated
Research
Application
System
Number
Name of Trial
108593
Doubleblind, randomized,
placebocontrolled, phase II dosefinding
study comparing different doses of
norursodeoxycholic acid capsules with
placebo in the treatment of primary
sclerosing cholangitis.
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Reason For
Closure Of
Trial
Comments
Strict eligibility criteria: Recruitment has
been difficult, in spite of rigorous
attempts to find eligible patients. For
example from the many hundred patients
on the patient database only 3 met the
criteria and only one of these responded
with interested. An eighth patient was
consented but was a screen failure in the
week before screening closed.
Number Agreed
8
8
Date Agreed
31/03/2015
5
26/05/2015
Recruitment
Finished
157949
Non-Comparative, Two-Cohort, Single
Arm, Open-Label, Phase 2 Study of
Nivolumab (BMS936558) in classical
Hodgkin Lymphoma (cHL) Subjects with Number Agreed
Relapsed or Progressive Disease after
Failure of Autologous Stem Cell Transplant
(ASCT)
3
3
Date Agreed
29/03/2021
9
25/08/2015
Recruitment
Finished
154256
A Multicentre, Multinational, Phase II
Study to Evaluate Pertuzumab in
Combination with Trastuzumab and
Standard Neoadjuvant AnthracyclineRange Agreed
Based Chemotherapy in Patients with
HER2-Positive Locally Advanced,
Inflammatory or Early-Stage Breast Cancer
4
6
Date Agreed
28/02/2016
4
23/06/2015
Recruitment
Finished
158617
A Single-Arm, Open-Label, Multicenter
Clinical Trial with Nivolumab (BMS936558) for Subjects with Histologically
Confirmed Stage III (unresectable) or
Number Agreed
Stage IV Melanoma Progressing Post Prior
Treatment Containing an Anti-CTLA-4
Monoclonal Antibody CheckM
3
3
Date Agreed
12/04/2018
6
29/03/2016
Recruitment
Finished
164329
A randomised, double-blind, placebocontrolled, parallel-group, multi-centre 24week study to evaluate the efficacy and
Number Agreed
safety of mepolizumab adjunctive therapy
in subjects with severe eosinophilic
asthma on markers of asthma control
6
6
Date Agreed
10/09/2015
2
06/08/2015
Recruitment
Finished
Insufficient number of patients seen:
Recruitment was terminated a month
early , at which point two patients were
being screened, which would have
improved recruitment
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Row No.
Research
Ethics
Committee
Reference
Number
Integrated
Research
Application
System
Number
Name of Trial
30
14/WM/1262
158454
An Open Label Study of Sofosbuvir/GS5816 Fixed-Dose Combination in Subjects
with Chronic HCV Infection
156161
A PHASE 2, RANDOMIZED, PLACEBO
CONTROLLED, DOUBLE BLIND PROOF-OFCONCEPT STUDY OF THE EFFICACY AND Number Agreed
SAFETY OF PF-02545920 IN SUBJECTS
WITH HUNTINGTON S DISEASE
6
6
Date Agreed
14/03/2016
158483
KCP-330-010 'A Phase 2 Study of the
Safety and Anti-tumor Activity of the Oral
Selective Inhibitor of Nuclear Export (SINE)
Range Agreed
Selinexor (KPT-330) in Patients with
Refractory and/or Relapsed Richter s
Transformation (RT)'
1
4
Date Agreed
136687
A Phase III randomized 3-arm, open label,
multicentre study of LGX818 plus MEK162
and LGX818 monotherapy compared with Number Agreed
vemurafenib in patients with unresectable
or metastic BRAF V600 mutant melanoma
3
3
149373
RESPONSE 'A randomised, double blind,
multi-center, placebo-controlled study to
evaluate the efficacy, safety, and
tolerability of NT100 in pregnant women
with a history of unexplained recurrent
pregnancy loss
Range Agreed
3
162258
A post market prospective study of the
VGS VEST (Venous External Support),
supporting saphenous vein grafts for
coronary bypass graft surgery in patients
with severe coronary heart disease
Range Agreed
15
31
32
33
34
35
14/YH/1112
14/SC/1284
13/SC/0478
14/NW/0130
14/EE/1106
Range Agreed
1
Reason For
Closure Of
Trial
Comments
06/05/2015
Recruitment
Finished
1
14/03/2016
Strict eligibility criteria: 5 subjects were
screened in total for this study, four of
Recruitment
whom went on to baseline. One
Finished
participant screen failed twice. Two of the
participants were entered into the MRI
sub study
31/07/2016
8
19/12/2015
Recruitment
Finished
Date Agreed
16/07/2016
1
06/10/2015
Recruitment
Finished
10
Date Agreed
31/07/2015
9
01/07/2015
Recruitment
Finished
30
Date Agreed
01/10/2015
30
08/10/2015
Recruitment
Finished
5
Date Agreed
23/03/2016
1
Closed to Recruitment: The trial closed to
recruitment 9 months earlier than
expected.
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Row No.
Research
Ethics
Committee
Reference
Number
Integrated
Research
Application
System
Number
Name of Trial
36
10/H0402/55
58047
An Open-Label, Multicenter, Efficacy and
Safety Study to Evaluate Two Treatment
Algorithms in Subjects with Moderate to
Severe Crohn's Disease
Range Agreed
4
10
Date Agreed
28/03/2017
6
04/09/2015
Recruitment
Finished
152516
A Phase 3, Multi-Center, Randomized,
Double-Blind, Placebo-Controlled, Study
of fostamatinib as compared with placebo Range Agreed
in achieving a stable platelet response in
subjects with persistent/chronic ITP
4
5
Date Agreed
30/08/2015
6
06/01/2016
Recruitment
Finished
120959
KAITLIN 'A Randomized, Multicenter,
Open-Label, Phase III Trial Comparing
Trastuzumab Plus Pertuzumab Plus a
Taxane Following Anthracyclines Versus Number Agreed
Trastuzumab Emtansine Plus Pertuzumab
Following Anthracyclines as Adjuvant
Therapy in Patients with Operable
37
38
14/EM/1059
13/EM/0460
7
7
Date Agreed
29/02/2016
0
Reason For
Closure Of
Trial
Comments
17/08/2015
Closed by Sponsor: Although TMA was
given on day 2 the sponsor delayed the
Withdrawn By
green light until Day 63. Recruitment was
Sponsor
promptly suspended on Day 80 and the
trial terminated early
39
14/NI/1075
161871
A Phase I/IIa Multicentre Study in
Otherwise Healthy Infants and Toddlers
Hospitalised For and Diagnosed With
Respiratory Syncytial Virus Lower
Respiratory Tract Infection, Consisting of
an Open-label Lead-in Part Followed by a
Double-blind, Placebo-contro
Range Agreed
1
3
Date Agreed
01/04/2016
0
16/12/2015
Strict eligibility criteria: During the whole
of January 2015 38 potential children
were pre-screened. None met the
inclusion criteria which was extremely
Recruitment disappointing. The trial moved out of the
Finished
RSV season and was put on hold. The trial
re-opened on 20th Oct and between then
and 18th Dec 2015 we pre-screened 124
participants none were suitable. The
sponsor has now closed recruitment.
40
14/WM/1228
166399
Evaluation of the Accuracy of the Abbott
Sensor Based Glucose Monitoring System - Range Agreed
Paediatric Label Extension Study (CE)
13
15
Date Agreed
31/05/2015
14
28/05/2015
Recruitment
Finished
Row No.
41
42
43
44
45
Research
Ethics
Committee
Reference
Number
13/EM/0424
15/SC/0012
14/LO/1053
14/YH/1153
15/LO/0034
Integrated
Research
Application
System
Number
Name of Trial
135977
A Phase 2, Dose-Finding, Randomized,
Parallel-Group, Double-Blind, PlaceboControlled Study, Evaluating the Safety
and Efficacy of Pridopidine 45 mg, 67.5
mg, 90 mg, and 112.5 mg Twice-Daily
versus Placebo for Symptomatic
Treatment in Patients with Hunting
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Number Agreed
167521
An open-label, non-randomized,
multicentre Phase 1 dose escalation study
to characterize safety, tolerability,
Number Agreed
pharmacokinetics and maximum tolerated
dose of BAY 1238097 in subjects with
advanced malignancies
158216
GS-US-352-0101 - A Phase 3, Randomized,
Double-blind Active-controlled Study
Evaluating Momelotinib vs. Ruxolitinib in
Subjects with Primary Myelofibrosis (PMF) Number Agreed
or Post-polycythemia Vera or Postessential Thrombocythemia Myelofibrosis
(Post-PV/ET MF)
159477
169816
An Open-Label, Extension Study of the
Effects of Leuco-methylthioninium
bis(hydromethanesulfonate) in Subjects
with Alzheimer?s Disease or Behavioral
Variant Frontotemporal Dementia
7
15
2
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
7
15
2
Not Available /
Not Agreed
A MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED, PARALLEL
GROUP STUDY TO EVALUATE THE
EFFICACY AND SAFETY OF TWO DOSE
Number Agreed
LEVELS OF BCX4161 FOR 12 WEEKS AS AN
ORAL PROPHYLAXIS TREATMENT FOR
ATTACKS OF HEREDITARY ANGIOEDEMA
Date Agreed
Date Agreed
Date Agreed
31/05/2015
28/04/2017
31/12/2017
6
5
1
Not Available
/ Not Agreed
2
2
Date Agreed
22/01/2016
1
31/05/2015
Reason For
Closure Of
Trial
Comments
No eligible patients consented: The study
was harder to recruit to than we initially
Recruitment expected, mainly due to the requirements
Finished
of a carer at a large number of visits.
Most of the carers work and are not able
to take that much time off.
Closed to recruitment by sponsor: This is
an early phase dose finding trial and the
sponsor closed the study to recruitment
much earlier than expected as the
Maximum Tolerated Dose of the study
drug was reached.
04/12/2015
Recruitment
Finished
25/02/2016
Rare disease and strict eligibility criteria,
sponsor closed recruitment early: the
target recruitment for this trial was 2 in 32
Recruitment
months. 3 additional patients were
Finished
approached but all three declined.
Sponsor then closed recruitment almost 2
years early.
31/08/2015
Recruitment into this trial is only open to
patients from TrX-238-005 or 7 or 8 or 15
and meet the inclusion criteria - no figures
Recruitment
are set. One participant was suitable from
Finished
the previous trials and was recruited but
withdrew early at which point the site
closed to recruitment.
01/10/2015
Recruitment
Finished
Closed to recruitment by sponsor:
Sponsor closed recruitment 3 months
early.
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Row No.
Research
Ethics
Committee
Reference
Number
Integrated
Research
Application
System
Number
Name of Trial
46
15/YH/0125
165426
An open label Phase 1b/2 study of ACP196 in subjects with waldenstroms
macroglobulinaemia (WM)
Number Agreed
2
2
Date Agreed
14/04/2018
3
08/12/2015
Recruitment
Finished
47
15/EM/0135
167922
An Open-label, Phase 2 Study of ACP-196
in Subjects with Mantle Cell Lymphoma
Range Agreed
2
3
Date Agreed
30/07/2018
1
03/12/2015
Recruitment
Finished
48
15/NW/0267
178494
Masked Performance Check of the Abbott
FreeStyle Libre Flash Glucose Monitoring
System
Range Agreed
10
72
Date Agreed
31/07/2025
14
12/10/2015
Recruitment
Finished
161714
An Open-Label, Phase 2a Study to
Evaluate the Pharmacodynamics of
Different Dosing Regimens of TAK-448, a
Kisspeptin Agonist, in Male
Number Agreed
Overweight/Obese Type 2 Diabetes
Mellitus Subjects With Hypogonadotropic
Hypogonadism
48
48
Date Agreed
01/10/2015
15
01/10/2015
Recruitment
Finished
117243
A Phase 2 Open-Label Study of the Efficacy
of ABT-199 (GDC-0199) in Subjects with
Relapsed or Refractory Chronic
Range Agreed
Lymphocytic Leukemia Harboring the 17p
Deletion
1
5
Date Agreed
31/10/2019
5
01/06/2015
Recruitment
Finished
180333
MK3475-087: A phase II clinical trial of MK3475 (pembrolizumab) in subjects with
Range Agreed
relapsed or refractory (R/R) classical
Hodgkin Lymphoma (cHL)
2
3
Date Agreed
16/08/2016
2
04/03/2016
Recruitment
Finished
49
50
51
52
14/LO/1950
13/EM/0340
15/NE/0252
15/EE/0261
180616
A Phase 3, Randomized, Double-blind,
Placebo-controlled Study to Evaluate the
Efficacy and Safety of AMG 334 in
Migraine Prevention
Range Agreed
6
10
Date Agreed
13/05/2016
0
25/01/2016
Reason For
Closure Of
Trial
Recruitment
Finished
Comments
Closed by sponsor - sponsor closed
recruitment early as they reached their
global recruitment target.
Study was an adaptive design and met the
aims of the sponsor with only 15 recruits.
(63 screen failures).
Strict eligibility criteria and sponsor
reached global recruitment early: Two
subjects were consented on day 26 and
day 33 from a patient pool of about 300
participants, unfortunately both were
screen failures. The sponsor then closed
recruitment four months early on day 81.
Row No.
53
54
Research
Ethics
Committee
Reference
Number
14/YH/0086
12/WM/0054
Integrated
Research
Application
System
Number
Name of Trial
Minimum
Number Of
Patients
Target Number Agreed
Of Patients
(Enter
Agreed?
Same In
Both If
Only One
Number)
Maximum
Number Of
Patients
Total Number
Target Date Date Agreed to
Agreed
Of Patients
Date That The
To Recruit
recruit target
(Enter
Recruited At Trial Closed To
Patients
number of
Same In
The Agreed
Recruitment
Agreed?
patients
Both If
Target Date
Only One
Number)
Reason For
Closure Of
Trial
Comments
147377
RESPOND: Repositionable Lotus Valve
System Post Market Evaluation of
Real World Clinical Outcomes
Range Agreed
20
50
Date Agreed
29/02/2016
11
01/02/2016
Sponsor closed recruitment early: The trial
finished early, it was due close on
February 29th but reached study
Recruitment
enrolment target by February 3rd. We
Finished
were on target to reach our enrolment
goal and had patients identified on Tavi
lists.
87735
A post market, long term, prospective,
observational, multisite outcome study to
follow the clinical course and seizure
reduction of patients with refractory
seizures who are being treated with
adjunctive VNS Therapy
Range Agreed
8
10
Date Agreed
01/04/2016
8
31/03/2016
Recruitment
Finished