Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

NCT ID: NCT03259334

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2020-10-23

Brief Summary

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ontamalimab 25 mg

Participants will receive 25 milligrams (mg) of ontamalimab (SHP647) subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.

Group Type: EXPERIMENTAL

Ontamalimab

Intervention Type: DRUG

Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

Ontamalimab 75 mg

Participants will receive 75 mg of ontamalimab (SHP647) SC injection using PFS on Week 0, Week 4 and Week 8.

Group Type: EXPERIMENTAL

Ontamalimab

Intervention Type: DRUG

Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

Placebo

Participants will receive placebo matched to ontamalimab (SHP647) SC injection using PFS on Week 0, Week 4 and Week 8.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive 1 mL of sterile aqueous buffered solution.

Interventions

Ontamalimab

Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

Intervention Type: DRUG

Placebo

Participants will receive 1 mL of sterile aqueous buffered solution.

Intervention Type: OTHER

Other Intervention Names

PF-00547659; SHP647

Eligibility Criteria

Inclusion Criteria

• Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Participants must be able to voluntarily provide written, signed, and dated informed consent and/or assent, as applicable, to participate in the study.
• Participants must be between greater than or equal to (>=)16 and <=80 years of age at the time of the signing of the informed consent/assent form.
• Participants less than (<) 18 years of age must weigh >=40 kg and must have body mass index (BMI) >=16.5 kilogram per square meter (kg/m^2).
• Participants must have a documented diagnosis of UC for >=3 months before screening. The following must be available in each participant's source documentation:

1. A biopsy report to confirm the histological diagnosis.

2. A report documenting disease duration based upon prior colonoscopy. Note: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.

• Participants must have moderate to severe active UC, defined as a total Mayo score of >=6, including a centrally read endoscopic subscore >=2, rectal bleeding subscore >=1, and stool frequency subscore >=1 at baseline.
• Participants must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
• Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate [ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]), or anti-tumor necrosis factor (TNF).
• Participants receiving any treatment(s) for UC are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
• Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential.

Exclusion Criteria

• Participants with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease.

• Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.)
• Participants with past medical history or presence of toxic megacolon.
• Participants with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
• Participants at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit, unless the participant has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.

Participants at risk for colorectal cancer include, but are not limited to:

1. Participants with extensive colitis for >=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >=10 years before screening, regardless of age.

2. Participants >=50 years of age at the time of signing of the informed consent form.

• Participants have had prior treatment with SHP647.

• Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.

• Participants have received anti-TNF treatment within 60 days before baseline.

• Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline.

• Participants have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline.

• Participants have ever received anti-integrin/adhesion molecule treatment (example (eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule).

• Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure.

• Participants have received leukocyte apheresis or selective lymphocyte, monocyte, or granulocyte apheresis or plasma exchange within 30 days before baseline.

• Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before baseline.

• Participants have received a live (attenuated) vaccine within 30 days before the baseline visit.

• Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [Participants with C. difficile infection at screening may be allowed re-test after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the participants to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit.

• Participants with abnormal chest x-ray findings at screening, such as presence of active tuberculosis, general infections, heart failure, or malignancy.

• Participants with evidence of active or latent infection with Mycobacterium tuberculosis (TB) or participants with this history who have not completed a generally accepted full course of treatment before randomization are excluded. All other participants must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin test or interferon gamma release assay (IGRA) performed.

Participants who have no history of previously diagnosed active or latent tuberculosis are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie >=5 millimeter [mm] induration) or a positive IGRA (the latter to be tested at the site's local laboratory) during screening or within 12 weeks before screening. If IGRA test cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor.

1. An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin (BCG) vaccination, but may be used for any participant. Documentation of IGRA product used and the test result must be in the participant's source documentation if performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube Test.

2. If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result is obtained, enrollment may proceed. In participants with no history of treated active or latent tuberculosis, a positive test on repeat will exclude the participant. Participants with a history of active or latent TB infection must follow instructions for "participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met" in this criterion.

3. Participants with repeat indeterminate IGRA results, with no prior TB history, may be enrolled after consultation with a pulmonary or infectious disease specialist who determines low risk of infection (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action). This consultation must be included in source documentation.

Results from a chest x-ray, taken within the 12 weeks before or during screening must show no abnormalities suggestive of active TB infection as determined by a qualified medical specialist.

Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met:

1. The participant has previously received an adequate course of treatment for either latent (eg, 9 months of isoniazid or an acceptable alternative regimen, in a locale where rates of primary multidrug TB resistance are <5%. Participants from regions with higher rates of primary multidrug TB resistance are excluded) or active (acceptable multidrug regimen) TB infection. Evidence of diagnosis and treatment must be included in source documentation. Consultation with a pulmonary or infectious disease specialist to confirm adequate treatment (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action) must be performed during the screening period. The consultation report must be included in source documentation prior to enrollment.

2. A chest x-ray performed within 12 weeks before or during screening indicates no evidence of active or recurrent disease, and documentation of interpretation by a qualified medical specialist must be included in source documentation.

• Participants with a pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening.
• Participants with any unexplained symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on the targeted neurological assessment during the screening period.
• Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.
• Participants with a significant concurrent medical condition at the time of screening or baseline, including, but not limited to, the following:

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1. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment will substantially increase the risk to the participant if he or she participates in the study.

2. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).

3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening.

4. History of significant cerebrovascular disease within 24 weeks before screening.

• Participants who have had significant trauma or major surgery within 4 weeks before the screening visit, or with any major elective surgery scheduled to occur during the study.
• Participants with evidence of cirrhosis with or without decompensation.
• Participants with primary sclerosing cholangitis.
• Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).

Note: If a participant tests negative for HBsAg, but positive for hepatitis B virus (HBcAb), the participant would be considered eligible if no presence of HBV DNA is confirmed by HBV DNA polymerasechainreaction(PCR) reflex testing performed in the central laboratory.

• Participants with chronic hepatitis C (HCV) (positive HCVAb and HCVRNA). Note: Participants who are HCVAb positive without evidence of HCVRNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks prior to baseline]).

• Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during screening.

Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once during the screening period for confirmation. Results must be reviewed for eligibility prior to the screening endoscopy procedure.

1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0×upper limit of normal (ULN).

2. Total bilirubin level >=1.5×ULN or >2.0×ULN if the participant has a known documented history of Gilbert's syndrome.

3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).

4. Platelet count <=100×10^9 per liter (/L) (100,000 cells per cubic millimeter [mm^3]) or >=1000×10^9/L (1,000,000 cells/mm^3).

5. White blood cell count <=3.5×10^9/L (3500 cells/mm^3). - Absolute neutrophil count (ANC)<2×10^9/L (2000 cells/mm^3).

• Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 ml/min/1.73m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.

Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.

• Participants with known human immunodeficiency virus (HIV) infection based on documented history, with positive serological test, or positive HIV serologic test at screening, tested at the site's local laboratory in accordance with country requirements or tested at the central laboratory.

Note: A documented negative HIV test within 6 months of screening is acceptable and does not need to be repeated.

• Participants who have, or who have a history of (within 2 years before screening), serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency of any kind, including abuse of medical marijuana (cannabis).

• Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

• Female participants who are planning to become pregnant during study period.
• Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
• Participants who are investigational site staff members or relatives of those site staff members or Participants who are Shire employees directly involved in the conduct of study.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Shire

Locations

Atria Clinical Research - Clinedge - PPDS

Little Rock, Arkansas, United States

OM Research LLC - Lancaster - ClinEdge - PPDS

Lancaster, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Asthma and Allergy Associates PC - CRN - PPDS

Colorado Springs, Colorado, United States

Advanced Clinical Research Network

Coral Gables, Florida, United States

Nuren Medical and Research Center

Miami, Florida, United States

Gastroenterology Group of Naples

Naples, Florida, United States

Omega Research Consultants LLC - Clinedge - PPDS

Orlando, Florida, United States

East Coast Institute for Research, LLC

Saint Augustine, Florida, United States

Gastrointestinal Diseases, Inc. Research

Columbus, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Medisphere Medical Research Center LLC

Evansville, Indiana, United States

Laporte County Institute For Clinical Research

Michigan City, Indiana, United States

Clinical Trials of SWLA LLC

Lake Charles, Louisiana, United States

Louisiana Research Center LLC

Shreveport, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Digestive Health Center PA

Ocean Springs, Mississippi, United States

New York Total Medical Care PC

Brooklyn, New York, United States

Piedmont Healthcare

Statesville, North Carolina, United States

Consultants For Clinical Research Inc

Cincinnati, Ohio, United States

Consultants For Clinical Research Inc

Cincinnati, Ohio, United States

Consultants For Clinical Research Inc

Fairfield, Ohio, United States

Allegheny Center For Digestive Health

Pittsburgh, Pennsylvania, United States

Digestive Disease Associates

Wyomissing, Pennsylvania, United States

Gastro One

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Advanced Gastroenterology-Union City

Union City, Tennessee, United States

Inquest Clinical Research/Coastal Gastroenterology Associates, PA

Baytown, Texas, United States

Northside Gastroenterology

Cypress, Texas, United States

DM Clinical Research - ERN - PPDS

Tomball, Texas, United States

HP Clinical Research

Bountiful, Utah, United States

Digestive Health Center at UWMC

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

CHI Franciscan Digestive Care Associates

Tacoma, Washington, United States

Exemplar Research, Inc. - Elkins

Elkins, West Virginia, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

St Vincents Hospital Melbourne - PPDS

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

A.ö. Krankenhaus der Barmherzigen Brüder

Sankt Veit an der Glan, Carinthia, Austria

LKH-Universitätsklinikum Klinikum Graz

Graz, Styria, Austria

Klinikum Klagenfurt Am Woerthersee

Klagenfurt, , Austria

Salzburger Landeskliniken

Salzburg, , Austria

Universitätsklinikum St. Pölten

Sankt Pölten, , Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, , Austria

Klinikum Wels-Grieskirchen GmbH

Wels, , Austria

Instituto Goiano de Gastroenterologia E Endoscopia Digestiva Ltda

Goiânia, Goiás, Brazil

Hospital Da Cidade de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos

Santo André, São Paulo, Brazil

University Hospital Center Zagreb

Zagreb, City of Zagreb, Croatia

Opca Bolnica Karlovac

Karlovac, Karlovacka Županija, Croatia

Opca bolnica Bjelovar

Bjelovar, , Croatia

Clinical Hospital Centre Osijek

Osijek, , Croatia

University Hospital Centre Split

Split, , Croatia

General Hospital Virovitica

Virovitica, , Croatia

General County Hospital Vukovar and Croatian Veterans Hospital

Vukovar, , Croatia

General Hospital Zadar

Zadar, , Croatia

Hepato-Gastroenterologie HK, s. r. o.

Hradec Králové, Královéhradecký kraj, Czechia

PreventaMed s.r.o.

Olomouc, Olomoucký kraj, Czechia

Institut Klinicke A Experimentalni Mediciny

Prague, , Czechia

ISCARE I.V.F. a.s.

Prague, , Czechia

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

Ústí nad Labem, , Czechia

Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice

Ústí nad Orlicí, , Czechia

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum der RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Gastro Campus Research GbR

Münster, North Rhine-Westphalia, Germany

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Jena

Jena, Thuringia, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Gastroenterologische Facharztpraxis am Mexikoplatz

Berlin-Zehlendorf, , Germany

Sana Klinikum Biberach

Biberach an der Riss, , Germany

Uniklinik Köln

Cologne, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Asklepios Westklinikum Hamburg Ggmbh

Hamburg, , Germany

Klinikum rechts der Isa der Technischen Universitaet Muenchen

Munich, , Germany

Shaare Zedek Medical Center

Jerusalem, , Israel

Hadassah Medical Center - PPDS

Jerusalem, , Israel

Galilee Medical Center

Nahariya, , Israel

Nazareth EMMS Hospital

Nazareth, , Israel

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, , Israel

Baruch Padeh Poriya Medical Center

Tiberias, , Israel

Ospedale Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo (FG), Apulia, Italy

Azienda Ospedaliera Mater Domini Di Catanzaro

Catanzaro, Calabria, Italy

Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, Emilia-Romagna, Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, Veneto, Italy

Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino - INCIPIT - PIN

Padua, Veneto, Italy

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, , Italy

A.O.U. Maggiore della Carità

Novara, , Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, , Italy

La Sapienza-Università di Roma-Policlinico Umberto I

Roma, , Italy

Fondazione Policlinico Universitario A Gemelli

Roma, , Italy

Istituto Clinico Humanitas

Rozzano (MI), , Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, , Italy

Sapporo Tokushukai Hospital

Sapporo, Hokkaidô, Japan

Sagamihara Kyodo Hospital

Sagamihara, Kanagawa, Japan

Jikei University Hospital

Minato-ku, Tokyo, Japan

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

Ome Municipal General Hospital

Ōme, Tokyo, Japan

Tokatsu Tsujinaka Hospital

Abiko-shi, Chiba, , Japan

Hakodate Koseiin Hakodate Goryoukaku Hospital

Hakodate, , Japan

Yuai Memorial Hospital

Koga, , Japan

Kawabe Clinic

Koganei, , Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, , Japan

Hidaka Coloproctology Clinic

Kurume-shi, , Japan

Aichi Medical University Hospital

Nagakute, , Japan

Nishinomiya Municipal Central Hospital

Nishinomiya, , Japan

Onomichi General Hospital

Onomichi, , Japan

Shiga University of Medical Science Hospital

Ōtsu, , Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, , Japan

Shinbeppu Hospital

Beppu, Ôita, Japan

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Vilnius City Clinical Hospital

Vilnius, , Lithuania

ETZ-Elisabeth

Tilburg, North Brabant, Netherlands

NWZ, location Alkmaar

Alkmaar, North Holland, Netherlands

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

VU Medisch Centrum

Amsterdam, , Netherlands

Academisch Medisch Centrum Amsterdam

Amsterdam, , Netherlands

Vitamed Galaj i Cichomski sp.j.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.

Włocławek, Kuyavian-Pomeranian Voivodeship, Poland

Krakowskie Centrum Medyczne

Krakow, Lesser Poland Voivodeship, Poland

Melita Medical

Wroclaw, Lower Silesian Voivodeship, Poland

Lexmedica

Wroclaw, Lower Silesian Voivodeship, Poland

Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

Lódz, Lódzkie, Poland

SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej UM w Lodzi

Lódz, Lódzkie, Poland

Instytut Centrum Zdrowia Matki Polki

Lódz, Lódzkie, Poland

Centrum Medyczne Warszawa - PRATIA - PPDS

Warsaw, Masovian Voivodeship, Poland

Niepubliczny Zakład Opieki Zdrowotnej VIVAMED

Warsaw, Masovian Voivodeship, Poland

Miedzyleski Szpital Specjalistyczny w Warszawie

Warsaw, Masovian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, Poland

Endoskopia Sp. z o.o.

Sopot, Pomeranian Voivodeship, Poland

H-T. Centrum Medyczne Endoterapia

Tychy, Silesian Voivodeship, Poland

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Szczecin, West Pomeranian Voivodeship, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, , Poland

Centrum Medyczne Czestochowa - PRATIA - PPDS

Częstochowa, , Poland

Centrum Medyczne Gdynia - PRATIA - PPDS

Gdynia, , Poland

BioVirtus Centrum Medyczne

Józefów, , Poland

Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach

Katowice, , Poland

NZOZ All Medicus

Katowice, , Poland

Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska

Krakow, , Poland

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

Ksawerów, , Poland

Med Gastr Sp.z.o.o Sp.k

Lodz, , Poland

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, , Poland

Centrum Innowacyjnych Terapii

Piaseczno, , Poland

Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa

Poznan, , Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, , Poland

Sonomed Sp. z o.o.

Szczecin, , Poland

Centrum Zdrowia MDM

Warsaw, , Poland

Centralny Szpital Kliniczny MSW

Warsaw, , Poland

Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

Zamość, , Poland

Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii

Gmina Końskie, Świętokrzyskie Voivodeship, Poland

Cluj-Napoca Emergency Clinical County Hospital

Cluj-Napoca, Cluj, Romania

Dr.Carol Davila Emergency University Central Military Hospital

Bucharest, , Romania

Sana Monitoring SRL

Bucharest, , Romania

Colentina Clinical Hospital

Bucharest, , Romania

Prof. Dr. Matei Bals Institute of Infectious Diseases

Bucharest, , Romania

Fundeni Clinical Institute

Bucharest, , Romania

Centrul Medical Hifu Terramed Conformal S.R.L.

Bucharest, , Romania

Affidea Romania SRL

Constanța, , Romania

Gastromedica SRL

Iași, , Romania

Dr. Tirnaveanu Amelita Private Practice

Oradea, , Romania

Dr. Goldis Gastroenterology Center SRL

Timișoara, , Romania

Kazan State Medical University

Kazan', , Russia

Moscow Clinical Scientific Center

Moscow, , Russia

Moscow Regional Research Clinical Institute Na Mfvladimirskiy

Moscow, , Russia

Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

Nizhny Novgorod, , Russia

Research Institute of Physiology and Basic Medicine

Novosibirsk, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

Union Clinic, LLC

Saint Petersburg, , Russia

St. Elizabeth Municipal Clinical Hospital

Saint Petersburg, , Russia

First St. Petersburg State Medical University n.a. I.P Pavlov

Saint Petersburg, , Russia

Russian Medical Military Academy n.a. S.M. Kirov

Saint Petersburg, , Russia

Medical University Reaviz

Samara, , Russia

Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city

Samara, , Russia

Medical Company Hepatolog, LLC

Samara, , Russia

SHI Regional Clinical Hospital

Saratov, , Russia

Smolensk Regional Clinical Hospital

Smoensk, , Russia

Stavropol State Medical University

Stavropol, , Russia

Regional Consulting and Diagnostics Centre

Tyumen, , Russia

Clinical Hospital Center ''Bezanijska Kosa''

Belgrade, , Serbia

University Clinical Center Nis

Niš, , Serbia

General Hospital Vrsac

Vršac, , Serbia

University Clinical Center Kragujevac

Kragujevac, Šumadijski Okrug, Serbia

CLINRESCO, ARWYP Medical Suites

Johannesburg, Gauteng, South Africa

Dr. J Breedt

Pretoria, Gauteng, South Africa

Dr JP Wright

Claremont, Western Cape, South Africa

Fairfield General Hospital - PPDS

Lancashire, Bury, United Kingdom

Pennine Acute Hospitals Trust

Lancashire, Bury, United Kingdom

Whipps Cross University Hospital

London, London, City of, United Kingdom

North Tyneside General Hospital

North Shields, Northumberland, United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, Shropshire, United Kingdom

Aberdeen Royal Infirmary - PPDS

Aberdeen, , United Kingdom

Western General Hospital Edinburgh - PPDS

Edinburh, , United Kingdom

Royal Gwent Hospital - PPDS

Newport, , United Kingdom

New Cross Hospital

Wolverhampton, , United Kingdom

Countries

United States; Australia; Austria; Brazil; Croatia; Czechia; Germany; Israel; Italy; Japan; Lithuania; Netherlands; Poland; Romania; Russia; Serbia; South Africa; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b5fdc4db2bf003ab4733d

To obtain more information on the study, click here/on this link

Other Identifiers

2017-000599-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SHP647-301

Identifier Type: -

Identifier Source: org_study_id