BERGAMOT: A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02394028
Collaborator
(none)
1,150
372
12
77.7
3.1
0

Study Details

Study Description

Brief Summary

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs.

The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease
Actual Study Start Date :
Mar 20, 2015
Actual Primary Completion Date :
Sep 9, 2021
Actual Study Completion Date :
Sep 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Induction Phase - Cohort 1 (Exploratory): Etrolizumab 210 mg

Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one subcutaneous (SC) injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

Drug: Etrolizumab
Etrolizumab will be administered as per regimen specified in individual arms.
Other Names:
  • RO5490261
  • RG7413
  • Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Experimental: Induction Phase - Cohort 1 (Exploratory): Etrolizumab 105 mg

    Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

    Drug: Etrolizumab
    Etrolizumab will be administered as per regimen specified in individual arms.
    Other Names:
  • RO5490261
  • RG7413
  • Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Placebo Comparator: Induction Phase - Cohort 1 (Exploratory): Placebo

    Cohort 1 enrolled participants first before Cohorts 2 and 3 in order to conduct an exploratory analysis on induction data. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.

    Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Experimental: Induction Phase - Cohort 2 (Open-Label): Etrolizumab 210 mg

    Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking for the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

    Drug: Etrolizumab
    Etrolizumab will be administered as per regimen specified in individual arms.
    Other Names:
  • RO5490261
  • RG7413
  • Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Experimental: Induction Phase - Cohort 2 (Open-Label): Etrolizumab 105 mg

    Cohort 2 is enrolling participants after Cohort 1 and is considered a "feeder" cohort to help achieve the necessary sample size for the Maintenance Phase. Participants randomized to this arm will receive one SC injection of open-label etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking of the dose of etrolizumab, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

    Drug: Etrolizumab
    Etrolizumab will be administered as per regimen specified in individual arms.
    Other Names:
  • RO5490261
  • RG7413
  • Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Experimental: Induction Phase - Cohort 3 (Pivotal): Etrolizumab 210 mg

    Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (210 mg) at Weeks 0, 2, 4, 8, and 12 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

    Drug: Etrolizumab
    Etrolizumab will be administered as per regimen specified in individual arms.
    Other Names:
  • RO5490261
  • RG7413
  • Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Experimental: Induction Phase - Cohort 3 (Pivotal): Etrolizumab 105 mg

    Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive one SC injection of etrolizumab (105 mg) at Weeks 0, 4, 8, 12 and one SC injection of etrolizumab-matching placebo at Week 2 during the 14-week Induction Phase. In order to preserve the masking, participants will also receive one SC injection of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12.

    Drug: Etrolizumab
    Etrolizumab will be administered as per regimen specified in individual arms.
    Other Names:
  • RO5490261
  • RG7413
  • Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Placebo Comparator: Induction Phase - Cohort 3 (Pivotal): Placebo

    Cohort 3 is the last to enroll participants (after Cohort 2) and will be the pivotal cohort for the Induction Phase. Participants randomized to this arm will receive two SC injections of etrolizumab-matching placebo at Weeks 0, 4, 8, and 12 (and one SC injection of etrolizumab-matching placebo at Week 2) during the 14-week Induction Phase, in order to preserve the masking.

    Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Placebo Comparator: Maintenance Phase - Placebo Responders: Placebo

    Participants who received placebo during the Induction Phase (from Cohorts 1 and 3) and achieved a CDAI-70 response at Week 14 will undergo a sham randomization into the Maintenance Phase. Placebo responders from induction will receive blinded maintenance treatment with an SC injection of placebo once every 4 weeks (q4w) from Week 16 to Week 64.

    Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Placebo Comparator: Maintenance Phase - Etrolizumab Responders: Placebo

    Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of placebo q4w from Week 16 to Week 64.

    Drug: Placebo
    Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.

    Experimental: Maintenance Phase - Etrolizumab Responders: Etrolizumab 105 mg

    Participants who received etrolizumab during the Induction Phase (from Cohorts 1-3) and achieved a CDAI-70 response at Week 14 without the use of rescue therapy will be re-randomized into the Maintenance Phase. Etrolizumab responders from induction who are re-randomized to this arm will receive blinded maintenance treatment with an SC injection of etrolizumab (105 mg) q4w from Week 16 to Week 64.

    Drug: Etrolizumab
    Etrolizumab will be administered as per regimen specified in individual arms.
    Other Names:
  • RO5490261
  • RG7413
  • No Intervention: Maintenance Phase - Non-Responders: Safety Follow-Up/GA29145

    All participants from Cohorts 1-3 who are considered non-responders after the Induction Phase at Week 14 may be eligible to enter the open-label extension study GA29145 (NCT02403323) and/or undergo a 12-week safety follow-up.

    Outcome Measures

    Primary Outcome Measures

    1. Induction Phase: Percentage of Participants with Clinical Remission at Week 14 [Baseline and Week 14]

      Clinical remission is defined as liquid/soft stool frequency (SF) mean daily score less than or equal (≤)3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    2. Induction Phase: Percentage of Participants with Endoscopic Improvement at Week 14 [Baseline and Week 14]

      Endoscopic improvement is defined as 50 percent (%) reduction from baseline in Simplified Endoscopic Index for Crohn's Disease (SES-CD) score.

    3. Maintenance Phase: Percentage of Participants with Clinical Remission at Week 66 [Baseline and Week 66]

      Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    4. Maintenance Phase: Percentage of Participants with Endoscopic Improvement at Week 66 [Baseline and Week 66]

      Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score.

    Secondary Outcome Measures

    1. Induction Phase: Percentage of Participants with Clinical Remission at Week 6 [Baseline and Week 6]

      Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    2. Induction Phase: Percentage of Participants with SES-CD Score ≤4 (≤2 for Ileal Participants), with No Segment Having a Subcategory Score Greater than (>)1, at Week 14 [Week 14]

    3. Induction Phase: Change from Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14 [Baseline and Week 14]

    4. Maintenance Phase: Percentage of Participants with Clinical Remission at Week 66, Among Those who Achieved Clinical Remission at Week 14 [Baseline, Weeks 14 and 66]

      Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    5. Maintenance Phase: Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 66, Among Those who Were Receiving Corticosteroids at Baseline [Baseline and Week 66]

      Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit.

    6. Maintenance Phase: Percentage of Participants with Endoscopic Improvement at Week 66 Among Participants who Achieved Endoscopic Improvement at Week 14 [Baseline, Weeks 14 and 66]

      Endoscopic improvement is defined as 50% reduction from baseline in SES-CD score.

    7. Maintenance Phase: Percentage of Participants with SES-CD Score ≤4 (≤2 for Ileal Participants), with No Segment Having a Subcategory Score >1, at Week 66 [Week 66]

    8. Maintenance Phase: Percentage of Participants with Durable Clinical Remission [Week 14 up to Week 66 (assessed at Weeks 24, 28, 32, 44, 56, and 66)]

      Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Durable clinical remission was defined as clinical remission at ≥4 of the 6 in-clinic assessment visits conducted during the Maintenance Phase at Weeks 24, 28, 32, 44, 56, and 66.

    9. Maintenance Phase: Percentage of Participants with Corticosteroid-Free Clinical Remission for at Least 24 Weeks at Week 66, Among Those who Were Receiving Corticosteroids at Baseline [Baseline and from Week 14 up to Week 66]

      Clinical remission is defined as SF mean daily score ≤3 and abdominal pain mean daily score ≤1, with no worsening in either subscore compared to baseline, averaged over the 7 days prior to visit. Percentage of participants with clinical remission who will be off corticosteroids for at least 24 weeks prior to Week 66 will be reported.

    10. Maintenance Phase: Change from Baseline in CD-PRO/SS Score at Week 66 [Baseline and Week 66]

    11. Overall Number of Participants who Experienced 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) [From Baseline up to Week 78]

    12. Overall Number of Participants with Adverse Events Leading to Study Drug Discontinuation [From Baseline up to Week 78]

    13. Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 [From Baseline up to Week 78]

    14. Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event [From Baseline up to Week 78]

    15. Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0 [From Baseline up to Week 78]

    16. Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0 [From Baseline up to Week 78]

    17. Overall Number of Participants who Develop Malignancies [From Baseline up to Week 78]

    18. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [Baseline, Pre-dose (Hour 0) on Weeks 4, 14, 24, 32, 44, 66 or early termination, 12 weeks after last dose (up to Week 78)]

    19. Observed Trough Serum Concentration (Cmin) of Etrolizumab [Pre-dose (Hour 0) at Baseline and Weeks 0, 10, 14, 16, 24, 28, 32, 44, and 66 or early termination (up to Week 66)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Moderately to severely active Crohn's Disease (CD) as determined by the CDAI, patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon

    • Intolerance, refractory disease, or no response to corticosteroids (CS), immunosuppressants (IS), or anti-TNF therapy within 5 years from screening. Participants who have not previously demonstrated inadequate response or intolerance to one or more anti-TNF therapies are eligible to participate in the study provided they are intolerant or refractory to CS or IS therapy

    • Use of effective contraception as defined by the protocol

    Exclusion Criteria:
    • A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome

    • Planned surgery for CD

    • Ileostomy or colostomy

    • Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab, as stated in the protocol)

    • Any prior treatment with ustekinumab within 14 weeks prior to randomization

    • Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG] vaccination must pass protocol-defined screening criteria)

    • Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical judgment of the investigator. Fistulas related to CD are not exclusionary

    • Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell adhesion molecule [anti-MAdCAM-1])

    • Any major episode of infection requiring treatment with intravenous antibiotics ≤8 weeks prior to screening or oral antibiotics ≤4 weeks prior to screening. Treatment with antibiotics as adjunctive therapy for CD in the absence of documented infection is not exclusionary

    • Hospitalization (other than for elective reasons) within 4 weeks prior to randomization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Valley Gastroenterology Consultants Arcadia California United States 91006
    2 University of California San Diego Medical Center La Jolla California United States 92093-5354
    3 VA Long Beach Healthcare System Long Beach California United States 90822
    4 Digestive Care Associates, A Medical Corporation San Carlos California United States 94070
    5 SDG Clinical Research San Diego California United States 92103
    6 University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition San Francisco California United States 94158
    7 Peak Gastroenterology Associates; Gastroenterology Colorado Springs Colorado United States 80907
    8 Innovative Medical Research of South Florida Aventura Florida United States 33180
    9 West Central Gastroenterology d/b/a Gastro Florida Clearwater Florida United States 33762
    10 University of Florida College of Medicine Gainesville Florida United States 32610
    11 Borland-Groover Clinic Jacksonville Florida United States 32256
    12 IMIC, Inc Miami Beach Florida United States 33140
    13 FQL Research, LLC Miramar Florida United States 33025
    14 Advanced Research Institute, Inc. Trinity Florida United States 34655
    15 Shafran Gastroenterology Center Winter Park Florida United States 32789
    16 Emory University Hospital Atlanta Georgia United States 30308
    17 Atlanta Gastroenterology Associates Atlanta Georgia United States 30342
    18 Gastrointestinal Diseases Research Columbus Georgia United States 31904
    19 Atlanta Center for Gastroenterology, PC Decatur Georgia United States 30033
    20 Gastroenterology Associates of Central Georgia Macon Georgia United States 31201
    21 Gastrointestinal Specialists of Georgia, PC Marietta Georgia United States 30060
    22 Advanced Clinical Research Meridian Idaho United States 83642
    23 Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology Chicago Illinois United States 60611
    24 The University of Chicago Medical Center Chicago Illinois United States 60637
    25 NorthShore University HealthSystem; Evanston Hospital Evanston Illinois United States 60201
    26 Southwest Gastroenterology; DM Clinical Research Oak Lawn Illinois United States 60453-3767
    27 Carle Foundation Hospital Urbana Illinois United States 61801-2500
    28 Cotton-O'Neil Clinical Research Center, Digestive Health Topeka Kansas United States 66606
    29 Gastroenterology Associates, LLC Baton Rouge Louisiana United States 70809
    30 Louisiana Research Center, LLC Shreveport Louisiana United States
    31 Commonwealth Clinical Studies Brockton Massachusetts United States 02302
    32 University of Michigan Health System Ann Arbor Michigan United States 48109-0666
    33 Gastroenterology Associates of Western Michigan, P.L.C. Grand Rapids Michigan United States 49506
    34 Center for Digestive Health Troy Michigan United States 48098
    35 Henry Ford Health System West Bloomfield Michigan United States 48322
    36 Mayo Clinic - Rochester; Gastrology Rochester Minnesota United States 55905
    37 University of Mississippi Medical Center; Division of Gastroenterology Jackson Mississippi United States 39216
    38 Ehrhardt Clinical Research, LLC Belton Missouri United States 64012
    39 Concorde Medical Group New York New York United States 10016
    40 Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) New York New York United States 10021
    41 Lenox Hill Hospital New York New York United States 10075
    42 University of North Carolina At Chapel Hill Chapel Hill North Carolina United States 27514
    43 Charlotte Gastroenterology and Hepatology, P.L.L.C Charlotte North Carolina United States 28207
    44 Kinston Medical Specialists Kinston North Carolina United States 28501
    45 Consultants for Clinical Research Inc. Cincinnati Ohio United States 45219
    46 Great Lakes Gastroenterology Research, LLC Mentor Ohio United States 44060
    47 Digestive Disease Specialists, Inc. Oklahoma City Oklahoma United States 73112
    48 Great Lakes Medical Research, LLC Harrisburg Pennsylvania United States 17110
    49 Innovative Clinical Research Greenville South Carolina United States 29604
    50 Gastroenterology Center of the MidSouth PC Germantown Tennessee United States 38138
    51 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    52 Texas Digestive Disease Consultants - Dallas Dallas Texas United States 75231
    53 University of Texas Southwestern Medical Center; Internal Medicne Dallas Texas United States 75390-9151
    54 Baylor College of Medicine; Gastroenterology Houston Texas United States 77030
    55 Methodist Hospital Research Institute Houston Texas United States 77030
    56 Wellness Clinical Research Center San Antonio Texas United States 78232
    57 Texas Digestive Disease Consultants - Southlake Southlake Texas United States 76092
    58 Tyler Research Institute, LLC Tyler Texas United States 75701
    59 Ericksen Research and Development Clinton Utah United States 84015
    60 University of Utah School of Medicine Salt Lake City Utah United States 84132
    61 McGuire Research Institute; Gastroenterology Richmond Virginia United States 23249
    62 Digestive Disease Institute; Virginia Mason Medical Center Seattle Washington United States 98101
    63 University of Wisconsin Madison Wisconsin United States 53792
    64 Hospital Italiano Buenos Aires Argentina C1181ACH
    65 The Canberra Hospital Garran Australian Capital Territory Australia 2065
    66 Bankstown-Lidcombe Hospital Bankstown New South Wales Australia 2200
    67 Concord Repatriation General Hospital Concord New South Wales Australia 2139
    68 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
    69 University of the Sunshine Coast Sippy Downs Queensland Australia 4556
    70 Mater Adult Hospital South Brisbane Queensland Australia 4101
    71 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    72 Flinders Medical Centre Bedford Park South Australia Australia 5042
    73 Monash Medical Centre Clayton Clayton Victoria Australia 3168
    74 St Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065
    75 Footscray Hospital; Gastroenterology Footscray Victoria Australia 3011
    76 St Frances Xavier Cabrini Hospital Malvern Victoria Australia 3144
    77 Alfred Hospital Melbourne Victoria Australia 3004
    78 Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics Parkville Victoria Australia 3050
    79 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
    80 LKH - Universitätsklinikum der PMU Salzburg Salzburg Austria 5020
    81 Medizinische Universität Wien Wien Austria 1090
    82 CHU St Pierre (St Pierre) Brussels Belgium 1000
    83 UZ Brussel Brussel Belgium 1090
    84 Hospital Erasme Bruxelles Belgium 1070
    85 UZ Antwerpen Edegem Belgium 2650
    86 AZ Maria Middelares Gent Belgium 9000
    87 UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy Leuven Belgium 3000
    88 Hospital Universitario Walter Cantidio - UFC Fortaleza CE Brazil 60430-370
    89 L2IP -Instituto de Pesquisas Clínicas Ltda. Brasilia DF Brazil 70200-730
    90 CEDOES - Diagnóstico e Pesquisa Vitoria ES Brazil 29055-450
    91 Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda Goiânia GO Brazil 74535-170
    92 Hospital Felicio Rocho Belo Horizonte MG Brazil 30110-068
    93 Eurolatino Pesquisas Médicas Ltda. Uberlandia MG Brazil 38411-186
    94 Centro Digestivo de Curitiba Curitiba PR Brazil 80430-160
    95 Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia Rio de Janeiro RJ Brazil 21941-590
    96 Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Rio de Janeiro RJ Brazil 22271-100
    97 Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit Passo Fundo RS Brazil 99010-080
    98 Hospital das Clinicas - UFRGS Porto Alegre RS Brazil 90035-903
    99 Hospital Ernesto Dornelles Porto Alegre RS Brazil 90160-092
    100 Oncoeste Pesquisa Clinica - HUST - Hospital Universitario Santa Terezinha Joacaba SC Brazil 89600-000
    101 UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu Botucatu SP Brazil 18618-970
    102 Allergisa Pesquisa Dermato-Cosmética Ltda Campinas SP Brazil 13084-791
    103 Pesquisare Saúde Sociedade Simples Santo Andre SP Brazil 09080-000
    104 Praxis Pesquisa Médica Santo Andre SP Brazil 09090-790
    105 Hospital Estadual Mario Covas Santo Andre SP Brazil 09190-610
    106 Hospital de Base de Sao Jose do Rio Preto Sao Jose do Rio Preto SP Brazil 15090-000
    107 Hospital Sírio-Libanês Sao Paulo SP Brazil 01308-050
    108 Universidade Federal de Sao Paulo - UNIFES Sao Paulo SP Brazil 04026-000
    109 Hospital do Servidor Público Estadual/HSPE-SP São Paulo SP Brazil 04039-901
    110 "City Clinic UMHAC" EOOD Sofia Bulgaria 1407
    111 UMHAT "Sv. Ivan Rilski", EAD Sofia Bulgaria 1431
    112 UMHAT Tsaritsa Yoanna - ISUL, EAD Sofia Bulgaria 1527
    113 University of Calgary Calgary Alberta Canada T2N 2T9
    114 Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology Edmonton Alberta Canada T6G 2X8
    115 (G.I.R.I.) GI Research Institute Vancouver British Columbia Canada V6Z 2K5
    116 Winnipeg Regional Health Authority Winnipeg Manitoba Canada R3A 1R9
    117 Queen Elizabeth II Health Sciences Centre; Gastroenterology Research Halifax Nova Scotia Canada B3H 1V7
    118 University Hospital - London Health Sciences Centre London Ontario Canada N6A 5A5
    119 Taunton Health Centre Oshawa Ontario Canada L1H 7K4
    120 The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit Ottawa Ontario Canada K1H 1A2
    121 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5
    122 Toronto Digestive Disease Associates Vaughan Ontario Canada L4L 4Y7
    123 Hôpital Maisonneuve - Rosemont Montreal Quebec Canada H1T 2M4
    124 McGill University Health Centre - Glen Site Montreal Quebec Canada H4A 3J1
    125 Royal University Hospital Saskatoon Saskatchewan Canada S7N 0W8
    126 Clinical Hospital Centre Osijek Osijek Croatia 31000
    127 General Hospital Pula Pula Croatia 52100
    128 Clinical Hospital Center Sestre Milosrdnice Zagreb Croatia 10000
    129 Clinical Hospital Sveti Duh Zagreb Croatia 10000
    130 University Hospital Center Zagreb Zagreb Croatia 10000
    131 Vojenska nemocnice Brno Brno Czechia 636 00
    132 Fakultni nemocnice u sv. Anny v Brne Brno Czechia 656 91
    133 Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia 370 01
    134 Gastroenterologie s.r.o. Hradec Kralove Czechia 500 02
    135 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    136 Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove Czechia 500 12
    137 PreventaMed, s.r.o. Olomouc Czechia 779 00
    138 Fakultni nemocnice Ostrava Ostrava - Poruba Czechia 708 52
    139 Klinicke centrum ISCARE Lighthouse Praha 7 Czechia 170 00
    140 Fakultni nemocnice Kralovske Vinohrady Praha Czechia 110 34
    141 West Tallinn Central Hospital Tallinn Estonia 10617
    142 North Estonia Medical Centre Foundation Tallinn Estonia 13419
    143 Tartu University Hospital Tartu Estonia 51014
    144 CHU Amiens - Hopital Sud Amiens France 80054
    145 CHU de Caen - Hopital Cote de Nacre Caen France 14033
    146 CHU Clermont Ferrand - Hôpital d'Estaing Clermont Ferrand cedex 1 France 63003
    147 Hôpital Beaujon Clichy cedex France 92110
    148 CHU de Grenoble - Hôpital Nord Grenoble France 38043
    149 Centre Hospitalier Départemental Les Oudairies La Roche sur Yon France 85025
    150 Hopital Claude Huriez - CHU Lille Lille France 59037
    151 CHU NANTES - Hôtel Dieu; Pharmacy Nantes France 44093
    152 CHU Nice - Hopital de l'Archet 2 Nice France 06202
    153 Hôpital Saint-Louis Paris France 75475
    154 Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN Pessac France 33604
    155 Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie Pierre-Benite France 69495
    156 CHU du Reims - Hopital Robert Debré Reims France 51092
    157 CHU Rennes - Hopital Pontchaillou Rennes cedex 09 France 35033
    158 CHU Saint Etienne - Hôpital Nord Saint Etienne France 42055
    159 Höpital Hautepierre; Pediatrie1 Strasbourg France 67098
    160 Hôpital de Brabois Adultes Vandoeuvre-les-nancy France 54511
    161 Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie Berlin Germany 13353
    162 Charité Campus Virchow-Klinikum; Department of Cardiology Berlin Germany 13353
    163 Krankenhaus Waldfriede e. V. Berlin Germany 14163
    164 Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH Bochum Germany 44789
    165 Staedisches Klinikum Brandenburg Brandenburg an der Havel Germany 14770
    166 Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden Dresden Germany 01307
    167 Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt Germany 60590
    168 Universitaetsklinikum Halle (Saale) Halle Germany 06120
    169 Gastroenterologie Hamburg Germany 20249
    170 Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept Hannover Germany 30625
    171 Universitaetsklinikum Schleswig-Holstein, Campus Kiel Kiel Germany 24116
    172 Universitätsklinikum Koeln Koeln Germany 50937
    173 Universitaetsklinikum Magdeburg A.oe.R; Division of Cardiology Magdeburg Germany 39120
    174 Klinikum Mannheim GmbH Universitätsklinikum Mannheim Germany 68167
    175 Universitaetsklinikum Muenster Muenster Germany 48149
    176 Klinikum rechts der Isar der Technischen Universität München Munchen Germany 81675
    177 Isar Klinik GmbH München Germany 80331
    178 Gemeinschaftspraxis Offenburg Germany 77652
    179 Universitaetsklinikum Tuebingen Tuebingen Germany 72076
    180 Universitaetsklinikum Ulm Ulm Germany 89081
    181 Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza Bekescsaba Hungary 5600
    182 Obudai Egeszsegugyi Centrum Kft. Budapest Hungary 1036
    183 Semmelweis Egyetem Budapest Hungary 1083
    184 Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo Budapest Hungary 1125
    185 Pannonia Maganorvosi Centrum Budapest Hungary 1135
    186 Debreceni Egyetem Debrecen Hungary 4032
    187 Petz Aladar Megyei Oktato Korhaz Gyor Hungary 9024
    188 Pest Megyei Flor Ferenc Korhaz Kistarcsa Hungary 2143
    189 Pecsi Tudomanyegyetem Pecs Hungary 7624
    190 Csongrad Megyei Dr. Bugyi Istvan Korhaz Szentes Hungary 6600
    191 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Székesfehérvár Hungary 8000
    192 Haemek Medical Center Afula Israel 18101
    193 Soroka University Medical Centre Beer Sheva Israel 8410101
    194 Wolfson Medical Center; Obstetrics and Gynecology Holon Israel 5822012
    195 Shaare Zedek Medical Center Jerusalem Israel 9103102
    196 Hadassah University Hospital - Ein Kerem Jerusalem Israel 9112001
    197 Holy Family Hospital Nazareth Israel 16100
    198 Rabin Medical Center-Beilinson Campus Petach Tikva Israel 4941492
    199 Tel Aviv Sourasky Medical Center; Pharmacy Tel Aviv Israel 6423906
    200 A.O.U. Policlinico di Modena Modena Emilia-Romagna Italy 40124
    201 Azienda Ospedaliera San Camillo Forlanini Roma Lazio Italy 00152
    202 Policlinico Universitario Agostino Gemelli; Farmacia Roma Lazio Italy 00168
    203 Asst Fatebenefratelli Sacco (Fatebenefratelli) Milano Lombardia Italy 20121
    204 ASST FATEBENEFRATELLI SACCO (Sacco) Milano Lombardia Italy 20157
    205 Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Milano Lombardia Italy 20162
    206 Ospedale di Circolo Rho Lombardia Italy 20017
    207 Istituto Clinico Humanitas Rozzano (MI) Lombardia Italy 20089
    208 I.R.C.C.S Policlinico San Donato San Donato Milanese (MI) Lombardia Italy 20097
    209 Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Milano Molise Italy 20122
    210 Ospedale Umberto I di Torino Torino Piemonte Italy 10128
    211 Azienda Ospedaliera Vincenzo Cervello Palermo Sicilia Italy 90127
    212 Azienda Ospedaliera Universitaria Careggi Firenze Toscana Italy 50141
    213 Inje University Busan Paik Hospital Busan Korea, Republic of 47392
    214 Dong-A University Hospital Busan Korea, Republic of 49201
    215 Pusan National University Hospital Busan Korea, Republic of 49241
    216 Kyungpook National University Hospital Daegu Korea, Republic of 41944
    217 Yeungnam Univ. Hospital Daegu Korea, Republic of 705-717
    218 Hanyang University Guri Hospital Gyeonggi-do Korea, Republic of 11923
    219 Korea University Ansan Hospital Gyeonggi-do Korea, Republic of 15355
    220 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13605
    221 CHA Bundang Medical Centre; CHA university Seongnam Korea, Republic of 13520
    222 Seoul National University Hospital Seoul Korea, Republic of 03080
    223 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    224 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    225 Asan Medical Center Seoul Korea, Republic of 05505
    226 Samsung Medical Center Seoul Korea, Republic of 06351
    227 Yonsei University Wonju Severance Christian Hospital Wonju-Si Korea, Republic of 220-701
    228 Riga East Clinical University Hospital; Clinic Gailezers Riga Latvia LV 1002
    229 Pauls Stradins Clinical University Hospital Rīga Latvia LV-1002
    230 Hospital of Lithuanian University of Health. Sciences Kaunas Clinics Kaunas Lithuania 50009
    231 Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology Vilnius Lithuania LT-08661
    232 Clinical Research Institute Tlalnepantla de Baz Mexico CITY (federal District) Mexico 54055
    233 Centro Regiomontano de Estudios Clínicos Roma S.C. Monterrey Nuevo LEON Mexico 64610
    234 Medical Care & Research SA de CV Mérida Yucatan Mexico 97070
    235 Amsterdam UMC, Locatie VUMC; Neurology Amsterdam Netherlands 1081 HV
    236 Amsterdam UMC Location AMC Amsterdam Netherlands 1105 AZ
    237 Leids Universitair Medisch Centrum Leiden Netherlands 2333 ZA
    238 Maastricht University Medical Center Maastricht Netherlands 6229 HX
    239 Erasmus Medisch Centrum Rotterdam Netherlands 3000 CA
    240 Zuyderland Medisch Centrum - Sittard Geleen Sittard-Geleen Netherlands 6162 BG
    241 ETZ TweeSteden Tilburg Netherlands 5042AD
    242 North Shore Hospital Auckland New Zealand 0620
    243 Christchurch Hospital NZ Christchurch New Zealand 8011
    244 Dunedin Public Hospital Dunedin New Zealand 9016
    245 Waikato Hospital Hamilton New Zealand 3248
    246 Shakespeare Specialist Group Takapuna New Zealand 0620
    247 Tauranga Hospital Tauranga New Zealand 3143
    248 SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego Białystok Poland 15-275
    249 Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz Poland 85-312
    250 Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ Elblag Poland 82-300
    251 ETG Kielce Kielce Poland 25-355
    252 Centrum Opieki Zdrowotnej Orkan-Med Ksawerow Poland 95-054
    253 Indywidualna Specjalistyczna Praktyka Lekarska Lublin Poland 20-015
    254 Allmedica Badania Kliniczne Sp z o.o. Sp K. Nowy Targ Poland 34-400
    255 Centrum Medyczne "MEDYK" Rzeszow Poland 35-055
    256 Gabinet Lekarski, Bartosz Korczowski Rzeszów Poland 35-302
    257 Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia Sopot Poland 81-756
    258 Niepubliczny Zaklad Opieki Zdrowotnej SONOMED Szczecin Poland 70-351
    259 Twoja Przychodnia-Szczecinskie Centrum Medyczne Szczecin Poland 71-434
    260 Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj Toruń Poland 87-100
    261 Centrum Zdrowia MDM Warszawa Poland 00-631
    262 Warsaw IBD Point Profesor Kierkus Warszawa Poland 00-728
    263 Zespó Przychodni Specjalistycznych PRIMA Warszawa Poland 02-018
    264 Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy Warszawa Poland 02-781
    265 LexMedica Osrodek Badan Klinicznych Wroclaw Poland 53-114
    266 EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu Wroclaw Poland 54-144
    267 PlanetMed sp. z o.o. Wrocław Poland 52-210
    268 AppleTreeClinics Sp. z o.o. Łódź Poland 90-349
    269 Spitalul Clinic Colentina Bucharest Romania 772202
    270 S.C MedLife S.A Bucuresti Romania 010719
    271 Centrul de Gastroenterologie Dr. Goldis Timisoara Romania 300002
    272 Yusupov Hospital Moskva Adygeja Russian Federation 127015
    273 LLC "Novosibirsk GastroCenter" Novosibirsk Altaj Russian Federation 630007
    274 Baltic Medicine St.Petersburg Leningrad Russian Federation 194356
    275 LLC Medinet Sankt-peterburg Sankt Petersburg Russian Federation 190103
    276 North-Western Medical University n.a. I.I. Mechnikov; Rheumatology Sankt-peterburg Sankt Petersburg Russian Federation 191015
    277 SBIH City Clinical Hospital #31 Sankt-peterburg Sankt Petersburg Russian Federation 197110
    278 SBEI HPE Altai StateMedicalUniversityofMoH andSD Barnaul Russian Federation 656050
    279 Irkutsk State Medical Academy of Continuing Education Irkutsk Russian Federation
    280 SBEIHPE Novosibirsk State Medical University Novosibirsk Russian Federation 630091
    281 BHI of Omsk region Clinical Oncology Dispensary Omsk Russian Federation 644013
    282 Evromedservis LCC Pushkin Russian Federation 196603
    283 SEIHPE "Rostov SMU of MoH of RF" Rostov-on-Don Russian Federation 344022
    284 Federal State Military Educational Institution; High Professional Education Military Medical Acad St. Petersburg Russian Federation 194044
    285 Pavlov First Saint Petersburg State Medical University St. Petersburg Russian Federation 197022
    286 Stavropol Regional Clinical Diagnostic Centre Stavropol Russian Federation 355040
    287 Clinical Helth Centre Zvezdara Belgrade Serbia 11000
    288 Military Medical Academy Belgrade Serbia 11040
    289 Clinical Center Zemun Belgrade Serbia 11080
    290 University Hospital Medical Center Bezanijska kosa Belgrade Serbia 11080
    291 Clinical Center Nis NIS Serbia 18000
    292 Clinical Center of Vojvodina Novi Sad Serbia 21000
    293 General Hospital Djordje Joanovic Zrenjanin Serbia 23000
    294 IBDcentrum s.r.o. Bratislava Slovakia 83104
    295 KM Management spol. s r.o. Nitra Slovakia 94901
    296 Endomed, s.r.o. Vranov nad Topľou Slovakia 093 01
    297 Accout Center s.r.o. Šahy Slovakia 936 01
    298 Dr D Epstein Practice Cape Town South Africa 7405
    299 Emmed Research Pretoria South Africa 0002
    300 Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
    301 Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies Majadahonda Madrid Spain 28222
    302 Hospital Clínic i Provincial; Servicio de Farmacia Barcelona Spain 08036
    303 Centro Médico Teknon Barcelona Spain
    304 Hospital Reina Sofia; Medical Oncology Cordoba Spain 14004
    305 Hospital Universitari de Girona Dr Josep Trueta Girona Spain 17007
    306 Hospital Juan Ramón Jiménez Huelva Spain 21005
    307 Hospital Universitario de la Princesa Madrid Spain 28006
    308 Hospital Universitario La Paz Madrid Spain 280146
    309 Hospital Universitario de Fuenlabrada Madrid Spain 28942
    310 Complejo Hospitalario de Pontevedra Pontevedra Spain 36071
    311 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    312 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    313 Hospital Universitari i Politecnic La Fe Valencia Spain 46026
    314 Hospital Universitario Miguel Servet Zaragoza Spain 50009
    315 Inselspital-Universitaetsspital Bern Bern Switzerland 3010
    316 Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner Bern Switzerland 3012
    317 Kantonsspital St.Gallen St. Gallen Switzerland 9007
    318 Universitätsspital Zürich Zürich Switzerland 8091
    319 Ankara University Medical Faculty Ankara Turkey 06100
    320 Hacettepe University Medical Faculty; Gastroenterology Ankara Turkey 06100
    321 Gazi University Medical Faculty Ankara Turkey 06500
    322 Acibadem Fulya Hospital; Neurology Istanbul Turkey 34349
    323 Haydarpasa Numune Training and Research Hospital; Medical Oncology Istanbul Turkey 34668
    324 Medeniyet University Goztepe Training and Research Hospital; Chest Diseases Istanbul Turkey 34722
    325 Ege University Medical Faculty Izmir Turkey 35100
    326 Kocaeli Universitesi Tip Fakultesi; Infectious Diseases Kocaeli Turkey 41380
    327 Acibadem Kozyatagi Hospital; Gastroenterology Kozyataği Turkey 34742
    328 Medical Center Dopomoga Plus Kyiv Chernihiv Governorate Ukraine 02123
    329 Municipal Noncommercial Enterprise City Clinical Hospital Lviv Chernihiv Governorate Ukraine 79011
    330 CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2 Kharkiv Kharkiv Governorate Ukraine 61037
    331 CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine Kharkiv Kharkiv Governorate Ukraine 61204
    332 Kyiv Clinical Hospital on Railway Station of Healthcare Center branch of JSC Kyiv Kharkiv Governorate Ukraine 01030
    333 Kyiv Railway Clinical Hospital#2 of Branch Health Center of the PJSC Kyiv Kharkiv Governorate Ukraine 03049
    334 Medical Center of Limited Liability Company Medical Clinic Blagomed Kyiv KIEV Governorate Ukraine 1023
    335 Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+" Kyiv KIEV Governorate Ukraine 2091
    336 CI of Kyiv RC Regional Clinical Hospital #2 Kyiv KIEV Governorate Ukraine 4073
    337 Salutas Medical Centre Lviv KIEV Governorate Ukraine 79005
    338 Lviv Regional Clinical Hospital Lviv KIEV Governorate Ukraine 79010
    339 Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk Kuban People's Republica Ukraine 76000
    340 RCNECRCH Dept of Surgery, SHEI Ukr BSMU Chernivtsi Podolia Governorate Ukraine 58002
    341 Khmelnytska Regional Hospital Khmelnytskyi Podolia Governorate Ukraine 29000
    342 Transcarpathian Regional Clinical Hospital n a Andriy Novak; Gastroenterology department Uzhgorod Polissya Okruha Ukraine 88000
    343 Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department Kremenchuk Poltava Governorate Ukraine 39617
    344 CI City Hospital #1 Zaporizhzhia Tavria Okruha Ukraine 69104
    345 Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council Lutsk Volhynian Governorate Ukraine 43005
    346 GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine Kharkiv Ukraine 61039
    347 CHI Kharkiv City Clinical Hospital #13 Kharkiv Ukraine 61124
    348 Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU Kyiv Ukraine 01030
    349 City Hospital #1 Mykolaiv Ukraine 54003
    350 Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2 Odesa Ukraine 65059
    351 Private Small Enterprise Medical Center Pulse Vinnytsia Ukraine 21001
    352 M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Vinnytsia Ukraine 21018
    353 MCIC MC LLC Health Clinic Vinnytsia Ukraine 21029
    354 CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU Zaporizhzhia Ukraine 69095
    355 LLC Diaservis Zaporizhzhia Ukraine 69106
    356 Royal Victoria Hospital Belfast United Kingdom BT12 6BA
    357 Addenbrooke's Hospital Cambridge United Kingdom CB2 0QQ
    358 University Hospital Coventry Coventry United Kingdom CV2 2DX
    359 Royal Devon and Exeter Hospital (Wonford) Exeter United Kingdom EX2 5DW
    360 St Mark's Hospital Harrow United Kingdom HA1 3UJ
    361 Queen Elizabeth Hospital Kings Lynn United Kingdom PE30 4ET
    362 St James University Hospital Leeds United Kingdom LS9 7TF
    363 Royal Liverpool University Hospital Liverpool United Kingdom L7 8XP
    364 Whipps Cross Hospital London United Kingdom E11 1NR
    365 University College London Hospital London United Kingdom NW1 - 2PG
    366 Fairfield General Hospital Manchester United Kingdom M8 5RB
    367 Royal Victoria Infirmary; Stroke unit Newcastle Upon Tyne United Kingdom NE1 4LP
    368 Nottingham University Hospitals Queen's Medical Centre Nottingham United Kingdom NG7 2UH
    369 Royal Berkshire Hospital Reading United Kingdom RG1 5AN
    370 Southampton General Hospital Southampton United Kingdom SO16 6YD
    371 Royal Stoke University Hospital Stoke-on-Trent United Kingdom ST4 6QG
    372 Royal Wolverhampton hospital; McHale Building Wolverhampton United Kingdom WV10 0QP

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02394028
    Other Study ID Numbers:
    • GA29144
    • 2014-003824-36
    First Posted:
    Mar 20, 2015
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2021