Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02100696




Registration number
NCT02100696
Ethics application status
Date submitted
27/03/2014
Date registered
1/04/2014
Date last updated
13/08/2021

Titles & IDs
Public title
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
Scientific title
Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors
Secondary ID [1] 0 0
2013-004278-88
Secondary ID [2] 0 0
GA28950
Universal Trial Number (UTN)
Trial acronym
HICKORY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etrozulimab
Treatment: Drugs - Placebo

Experimental: Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase) - Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.

Placebo comparator: Cohort 2: Placebo (Double-Blind Induction Phase) - Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.

Experimental: Cohort 2: Etrolizumab (Double-Blind Induction Phase) - Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.

Placebo comparator: Placebo Responders: Placebo (Maintenance Phase) - Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.

Placebo comparator: Etrolizumab Responders: Placebo (Maintenance Phase) - Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.

Experimental: Etrolizumab Responders: Etrolizumab (Maintenance Phase) - Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.


Treatment: Drugs: Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.

Treatment: Drugs: Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Phase: Percentage of Participants With Remission at Week 14, as Determined by the Mayo Clinic Score (MCS)
Timepoint [1] 0 0
Week 14
Primary outcome [2] 0 0
Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved a Clinical Response at Week 14, as Determined by the MCS
Timepoint [2] 0 0
Week 66
Secondary outcome [1] 0 0
Induction Phase: Percentage of Participants With Clinical Remission at Week 14, as Determined by the MCS
Timepoint [1] 0 0
Week 14
Secondary outcome [2] 0 0
Induction Phase: Percentage of Participants With Clinical Response at Week 14, as Determined by the MCS
Timepoint [2] 0 0
Week 14
Secondary outcome [3] 0 0
Induction Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 14, as Determined by the MCS Endoscopic Subscore
Timepoint [3] 0 0
Baseline and Week 14
Secondary outcome [4] 0 0
Induction Phase: Percentage of Participants With Endoscopic Remission at Week 14, as Determined by the MCS Endoscopic Subscore
Timepoint [4] 0 0
Week 14
Secondary outcome [5] 0 0
Induction Phase: Percentage of Participants With Histologic Remission at Week 14, as Determined by the Nancy Histological Index
Timepoint [5] 0 0
Week 14
Secondary outcome [6] 0 0
Induction Phase: Change From Baseline to Week 6 in MCS Rectal Bleed Subscore
Timepoint [6] 0 0
Baseline and Week 6
Secondary outcome [7] 0 0
Induction Phase: Change From Baseline to Week 6 in MCS Stool Frequency Subscore
Timepoint [7] 0 0
Baseline and Week 6
Secondary outcome [8] 0 0
Induction Phase: Change From Baseline to Week 14 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire
Timepoint [8] 0 0
Baseline and Week 14
Secondary outcome [9] 0 0
Induction Phase: Change From Baseline to Week 14 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Timepoint [9] 0 0
Baseline and Week 14
Secondary outcome [10] 0 0
Induction Phase: Change From Baseline to Week 14 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [10] 0 0
Baseline and Week 14
Secondary outcome [11] 0 0
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66 Among Participants Who Had Achieved Clinical Remission at Week 14, as Determined by the MCS
Timepoint [11] 0 0
Week 66
Secondary outcome [12] 0 0
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, as Determined by the MCS
Timepoint [12] 0 0
Week 66
Secondary outcome [13] 0 0
Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved Remission at Week 14, as Determined by the MCS
Timepoint [13] 0 0
Week 66
Secondary outcome [14] 0 0
Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 66, as Determined by the MCS Endoscopic Subscore
Timepoint [14] 0 0
Baseline and Week 66
Secondary outcome [15] 0 0
Maintenance Phase: Percentage of Participants With Histologic Remission at Week 66, as Determined by the Nancy Histological Index
Timepoint [15] 0 0
Week 66
Secondary outcome [16] 0 0
Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 66, as Determined by the MCS Endoscopic Subscore
Timepoint [16] 0 0
Week 66
Secondary outcome [17] 0 0
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS
Timepoint [17] 0 0
Week 66
Secondary outcome [18] 0 0
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS
Timepoint [18] 0 0
Week 66
Secondary outcome [19] 0 0
Maintenance Phase: Change From Baseline to Week 66 in UC Bowel Movement Signs and Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Timepoint [19] 0 0
Baseline and Week 66
Secondary outcome [20] 0 0
Maintenance Phase: Change From Baseline to Week 66 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Timepoint [20] 0 0
Baseline and Week 66
Secondary outcome [21] 0 0
Maintenance Phase: Change From Baseline to Week 66 in Health-Related Quality of Life, as Assessed by the Overall Score of the IBDQ
Timepoint [21] 0 0
Baseline and Week 66
Secondary outcome [22] 0 0
Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
Timepoint [22] 0 0
From Baseline up to Week 78
Secondary outcome [23] 0 0
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Timepoint [23] 0 0
From Baseline up to Week 78
Secondary outcome [24] 0 0
Number of Participants With Serious Infection-Related Adverse Events
Timepoint [24] 0 0
From Baseline up to Week 78
Secondary outcome [25] 0 0
Number of Participants With Infection-Related Adverse Events
Timepoint [25] 0 0
From Baseline up to Week 78
Secondary outcome [26] 0 0
Number of Participants With Injection-Site Reaction-Related Adverse Events
Timepoint [26] 0 0
From Baseline up to Week 78
Secondary outcome [27] 0 0
Number of Participants With Hypersensitivity Reaction-Related Adverse Events
Timepoint [27] 0 0
From Baseline up to Week 78
Secondary outcome [28] 0 0
Number of Participants With Malignancies
Timepoint [28] 0 0
From Baseline up to Week 78
Secondary outcome [29] 0 0
Number of Participants With Anti-Therapeutic Antibodies to Etrolizumab at Baseline and During the Study
Timepoint [29] 0 0
Pre-dose at Baseline, Weeks 4, 14, 24, 44, and 66, and Early Termination/End of Safety Follow-Up (up to Week 78)
Secondary outcome [30] 0 0
Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ)
Timepoint [30] 0 0
Pre-dose (0 hour) at Baseline and Weeks 14, 24, 44 and 66
Secondary outcome [31] 0 0
Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ)
Timepoint [31] 0 0
Weeks 44 and 66

Eligibility
Key inclusion criteria
* Diagnosis of UC established at least 3 months prior to Day 1
* Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
* Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
* Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
* Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
* Use of highly effective contraception as defined by the protocol
* Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
* Prior or planned surgery for UC
* Past or present ileostomy or colostomy
* Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
* Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
* Any prior treatment with rituximab
* Any treatment with tofacitinib during screening
* Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
* Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
* Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
* History of recurrent opportunistic infections and/or severe disseminated viral infections
* History of organ transplant
* Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
* Received a live attenuated vaccine within 4 weeks prior to Day 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/04/2020
Sample size
Target
Accrual to date
Final
609
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Launceston General Hospital; Gastroenterology Research - Launceston
Recruitment hospital [5] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Footscray Hospital; Gastroenterology - Footscray
Recruitment hospital [7] 0 0
St Frances Xavier Cabrini Hospital - Malvern
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
7250 - Launceston
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Argentina
State/province [20] 0 0
Rosario
Country [21] 0 0
Austria
State/province [21] 0 0
Klagenfurt
Country [22] 0 0
Austria
State/province [22] 0 0
Salzburg
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Belgium
State/province [24] 0 0
Bonheiden
Country [25] 0 0
Belgium
State/province [25] 0 0
Brussels
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussel
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Herentals
Country [29] 0 0
Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Belgium
State/province [30] 0 0
Liège
Country [31] 0 0
Belgium
State/province [31] 0 0
Roeselare
Country [32] 0 0
Brazil
State/province [32] 0 0
GO
Country [33] 0 0
Brazil
State/province [33] 0 0
MG
Country [34] 0 0
Brazil
State/province [34] 0 0
PR
Country [35] 0 0
Brazil
State/province [35] 0 0
RJ
Country [36] 0 0
Brazil
State/province [36] 0 0
RS
Country [37] 0 0
Brazil
State/province [37] 0 0
SP
Country [38] 0 0
Canada
State/province [38] 0 0
Alberta
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Nova Scotia
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Czechia
State/province [43] 0 0
Brno
Country [44] 0 0
Czechia
State/province [44] 0 0
Hradec Kralove
Country [45] 0 0
Czechia
State/province [45] 0 0
Pardubice
Country [46] 0 0
Czechia
State/province [46] 0 0
Prague
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 7
Country [48] 0 0
Czechia
State/province [48] 0 0
Usti Nad Labem
Country [49] 0 0
Denmark
State/province [49] 0 0
København Ø
Country [50] 0 0
Denmark
State/province [50] 0 0
Ålborg
Country [51] 0 0
France
State/province [51] 0 0
Amiens Cedex01
Country [52] 0 0
France
State/province [52] 0 0
Clichy cedex
Country [53] 0 0
France
State/province [53] 0 0
Lille
Country [54] 0 0
France
State/province [54] 0 0
Marseille cedex 20
Country [55] 0 0
France
State/province [55] 0 0
Nice
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
France
State/province [57] 0 0
Pessac
Country [58] 0 0
France
State/province [58] 0 0
Saint Etienne
Country [59] 0 0
France
State/province [59] 0 0
Strasbourg
Country [60] 0 0
France
State/province [60] 0 0
Toulouse Cedex 09
Country [61] 0 0
France
State/province [61] 0 0
Vandoeuvre-les-nancy
Country [62] 0 0
Germany
State/province [62] 0 0
Berlin
Country [63] 0 0
Germany
State/province [63] 0 0
Erlangen
Country [64] 0 0
Germany
State/province [64] 0 0
Frankfurt
Country [65] 0 0
Germany
State/province [65] 0 0
Freiburg
Country [66] 0 0
Germany
State/province [66] 0 0
Halle
Country [67] 0 0
Germany
State/province [67] 0 0
Hamburg
Country [68] 0 0
Germany
State/province [68] 0 0
Hannover
Country [69] 0 0
Germany
State/province [69] 0 0
Kiel
Country [70] 0 0
Germany
State/province [70] 0 0
Mannheim
Country [71] 0 0
Germany
State/province [71] 0 0
Muenster
Country [72] 0 0
Germany
State/province [72] 0 0
Ulm
Country [73] 0 0
Greece
State/province [73] 0 0
Thessaloniki
Country [74] 0 0
Hungary
State/province [74] 0 0
Bekescsaba
Country [75] 0 0
Hungary
State/province [75] 0 0
Budapest
Country [76] 0 0
Hungary
State/province [76] 0 0
Debrecen
Country [77] 0 0
Hungary
State/province [77] 0 0
Eger
Country [78] 0 0
Hungary
State/province [78] 0 0
Gyor
Country [79] 0 0
Hungary
State/province [79] 0 0
Miskolc
Country [80] 0 0
Hungary
State/province [80] 0 0
Pecs
Country [81] 0 0
Hungary
State/province [81] 0 0
Székesfehérvár
Country [82] 0 0
Israel
State/province [82] 0 0
Jerusalem
Country [83] 0 0
Israel
State/province [83] 0 0
Petach Tiqwa
Country [84] 0 0
Israel
State/province [84] 0 0
Rehovot
Country [85] 0 0
Israel
State/province [85] 0 0
Rishon Lezion
Country [86] 0 0
Italy
State/province [86] 0 0
Emilia-Romagna
Country [87] 0 0
Italy
State/province [87] 0 0
Lazio
Country [88] 0 0
Italy
State/province [88] 0 0
Lombardia
Country [89] 0 0
Italy
State/province [89] 0 0
Toscana
Country [90] 0 0
Italy
State/province [90] 0 0
Veneto
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Daegu
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Gyeonggi-do
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Seongnam-si
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Seoul
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Suwon-si,
Country [96] 0 0
Lithuania
State/province [96] 0 0
Kaunas
Country [97] 0 0
Lithuania
State/province [97] 0 0
Vilnius
Country [98] 0 0
Mexico
State/province [98] 0 0
Nuevo LEON
Country [99] 0 0
Netherlands
State/province [99] 0 0
Amsterdam
Country [100] 0 0
Netherlands
State/province [100] 0 0
Arnhem
Country [101] 0 0
Netherlands
State/province [101] 0 0
NL -nijmegen
Country [102] 0 0
Poland
State/province [102] 0 0
Bydgoszcz
Country [103] 0 0
Poland
State/province [103] 0 0
Katowice
Country [104] 0 0
Poland
State/province [104] 0 0
Rzeszów
Country [105] 0 0
Poland
State/province [105] 0 0
Szczecin
Country [106] 0 0
Poland
State/province [106] 0 0
Warszawa
Country [107] 0 0
Poland
State/province [107] 0 0
Wroclaw
Country [108] 0 0
Romania
State/province [108] 0 0
Bucuresti
Country [109] 0 0
Spain
State/province [109] 0 0
Madrid
Country [110] 0 0
Spain
State/province [110] 0 0
Girona
Country [111] 0 0
Spain
State/province [111] 0 0
Valencia
Country [112] 0 0
Spain
State/province [112] 0 0
Zaragoza
Country [113] 0 0
Switzerland
State/province [113] 0 0
Bern
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Cambridge
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Exeter
Country [116] 0 0
United Kingdom
State/province [116] 0 0
London
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Manchester
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Newcastle upon Tyne
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Nottingham
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02100696