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Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease (MAPUS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by RedHill Biopharma Limited
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited
ClinicalTrials.gov Identifier:
NCT01951326
First received: September 19, 2013
Last updated: March 22, 2017
Last verified: October 2016
  Purpose
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.

Condition Intervention Phase
Crohn's Disease
Drug: RHB-104
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by RedHill Biopharma Limited:

Primary Outcome Measures:
  • Remission at week 26 [ Time Frame: Baseline to week 26 ]
    Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150


Secondary Outcome Measures:
  • Response at week 26 [ Time Frame: Baseline to week 26 ]
    Reduction of CDAI score by a minimum of 100 points

  • Time to remission and response [ Time Frame: Baseline through week 52 ]
    The time (weeks after randomization) that a subject first records a state of remission or response.

  • Duration of remission and response [ Time Frame: Baseline through week 52 ]
    The time that a subject is in a state of remission or response.

  • Maintenance of remission [ Time Frame: 52 weeks ]
    Remission in a subject from week 26 through week 52.


Other Outcome Measures:
  • Proportion of subjects in remission [ Time Frame: 52 Weeks ]
  • Proportion of subjects who maintained remission [ Time Frame: Baseline to week 52 ]
  • RHB-104 plasma concentration measurements at different time points [ Time Frame: Baseline through week 56 ]
  • Changes in MAP blood status by polymerase chain reaction (PCR) [ Time Frame: Baseline through week 26 ]
  • Change in Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: Baseline through week 26 ]
  • Change in Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form 36 (SF-36) [ Time Frame: Baseline through Week 52 ]
  • Change in inflammatory markers [ Time Frame: Baseline through Week 52 ]
  • Proportion of subjects tapered off steroids [ Time Frame: Baseline through Week 52 ]
  • Tissue levels of the active agents of RHB-104 in colon biopsy samples [ Time Frame: Baseline to Week 26 ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline through Week 56 ]

Estimated Enrollment: 410
Study Start Date: September 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RHB-104
5 RHB-104 capsules administered orally BID
Drug: RHB-104
95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
Placebo Comparator: Placebo
5 placebo capsules administered orally BID
Drug: Placebo
5 placebo capsules administered orally BID

Detailed Description:
A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn's Disease.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Signed fully informed consent provided as per this protocol.
  2. Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study.
  3. CD involving the ileum and/or colon
  4. Moderately to severely active CD (Crohn's Disease Activity Index (CDAI) score of less than or equal to 220 and less than or equal to 450) at baseline.
  5. Current treatment with at least one of the following therapies:

    A. Oral 5-acetyl salicylic acid (5-ASA) compounds. Dose must be stable for at least 4 weeks before baseline.

    B. Corticosteroid therapy. Dose must be stable for at least 2 weeks before baseline.

    C. Azathioprine or 6-mercaptopurine (6-MP) or methotrexate. Dose must be stable for at least 8 weeks before baseline.

    D. Infliximab or adalimumab. Dose must be stable for at least 14 weeks before baseline.

  6. White blood cell count greater than or equal to 3.5 x 109 at screening.
  7. Active Crohn's disease, defined by at least one of the following: C-reactive protein greater than Upper Limit of Normal (ULN) at screening, fecal calprotectin greater than Upper Limit of Normal (ULN) at screening, OR radiographic (MRE or CTE) or endoscopic confirmation of the presence of active CD within 5 weeks of screening visit. .
  8. Subject agrees to use barrier contraceptive methods (i.e. diaphragm, cervical cap, contraceptive sponge or condom) with spermicidal foam/gel/cream/suppository, IUD/IUS or progestogen injection (Depo-Provera®) throughout the study and for at least 6 weeks after last study drug administration, unless subject is post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation, or has had a vasectomy. In regions where local regulatory contraceptive requirements differ, the ICF will reflect local policies.

Exclusion Criteria

  1. Crohn's Disease involvement isolated to the mouth, upper gastrointestinal tract, or anus.
  2. History of total colectomy with ileorectal anastomosis or a proctocolectomy.
  3. Presence of active fistulizing Crohn's Disease or healed fistula within 2 months prior to screening.
  4. Subject has postoperative stoma, ostomy, or ileoanal pouch.
  5. Subject has short bowel syndrome.
  6. Subject is scheduled for surgical bowel resection.
  7. Subject has known symptomatic obstructive strictures or bowel perforation in the 6 months prior to screening.
  8. Change in dose or discontinuation of oral 5-acetyl salicylic acid (5-ASA) compounds less than 4 weeks prior to baseline.
  9. Change in dose or discontinuation of corticosteroids less than 2 weeks prior to baseline.
  10. Change in dose or discontinuation of azathioprine, 6-mercaptopurine (6-MP) or methotrexate less than 8 weeks prior to baseline.
  11. Change in dose or discontinuation of infliximab or adalimumab less than 14 weeks prior to baseline.
  12. Treatment with vedolizumab less than 120 days prior to baseline or biological therapies (apart from infliximab or adalimumab) less than 60 days prior to baseline.
  13. Previous treatment with rifabutin and/or clofazimine.
  14. Oral or parenteral antibiotics in the 4 weeks prior to baseline (topical antibiotics are permitted).
  15. Treatment with probiotics (excluding yogurt and yogurt-derived products) in the 4 weeks prior to baseline.
  16. Females who have a positive pregnancy test or are lactating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951326

Contacts
Contact: Ira N Kalfus, MD ira@redhillbio.com
Contact: To see if you might qualify http://www.mapmycrohns.com

  Hide Study Locations
Locations
United States, Arizona
Del Sol Research Management, 850 N Knob Road Recruiting
Tucson, Arizona, United States, 85710
Contact: Maria Gallegos    520-635-4515    mgallegos@delsolresearch.com   
Principal Investigator: Gary Gottlieb, MD         
United States, California
Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303 Active, not recruiting
Anaheim, California, United States, 92801
Medvin Clinical Research, 15627 Imperial Highway, Recruiting
La Mirada, California, United States, 90638
Contact: Maria Gonzales    562-479-0330    maria@medvinresearch.com   
Principal Investigator: Richard McGuire, MD         
Digestive Care Associats, Inc., 1000 Laurel St. Recruiting
San Carlos, California, United States, 94070
Contact: MaryAnn Braesesco    650-596-8800    studysite@sbcglobal.net   
Principal Investigator: Scott Levenson, MD         
Ventura Clinical Trials, 1835 Knoll Drive Recruiting
Ventura, California, United States, 93003
Contact: Alex Martinez    805-339-0549    martineza1504@gmail.com   
Principal Investigator: Sabine Hazan, MD         
United States, Connecticut
Medical Research Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Contact: Jennifer Nikolich, RN    203-281-5161    jNikolich@gastrocenter.org   
Principal Investigator: Philip Ginsburg, MD         
United States, Florida
Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330 Recruiting
Aventura, Florida, United States, 33180
Contact: Gabriel Barba    786-202-0998    gbmdresearch@live.com   
Principal Investigator: Isaac Bassan, MD         
Clinical Research of West Florida Recruiting
Clearwater, Florida, United States, 33765
Contact: Margaret Gray, ARNP    727-466-0078 ext 230    mgray@crwf.com   
Principal Investigator: Michael Weiss, MD         
Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111 Recruiting
Lauderdale Lakes, Florida, United States, 33319
Contact: Sheri P. Alleyne    954-915-9991    sheria@sunrisemedresearch.com   
Principal Investigator: Jeffrey Schneider, MD         
Gastroenterology Group of Naples, 1064 Goodlette Road Recruiting
Naples, Florida, United States, 34102
Contact: Rose Furgal, RN    239-649-1336    rfurgalresearch@embarqmail.com   
Principal Investigator: Raymond W Phillips, MD         
Advanced Research Institute Inc., 7114 Congress Street Recruiting
New Port Richey, Florida, United States, 34653
Contact: Christina Arel    727-835-3261    carel@advancedresearchinstitute.net   
Principal Investigator: Curtis Freedland, MD         
Endoscopic Research, Inc., 1817 North Mills Avenue Recruiting
Orlando, Florida, United States, 32802
Contact: Christina Pacheco    407-241-3289    research@cdhfl.com   
Principal Investigator: William Ruderman, MD         
Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110 Recruiting
Port Orange, Florida, United States, 32127
Contact: Andrea Georgiou    386-767-8800    ageorgiou@amrcus.com   
Principal Investigator: Ammar Hemaidan, MD         
United States, Georgia
Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550 Recruiting
Decatur, Georgia, United States, 30033
Contact: Sharli Maxwell    404-296-1986    smaxwell@acgaec.com   
Principal Investigator: David Rausher, MD         
Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300 Recruiting
Marietta, Georgia, United States, 30060
Contact: Crea C. Beal    678-819-4237    cbeal@gigeorgia.com   
Principal Investigator: Aasim Sheikh, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Annika Gorenz    312-563-3907    annika.gorenz@rush.edu   
Contact    312-942-1181      
Principal Investigator: Ece Mutlu, MD         
The Carle Foundation, 611 West Park Street Recruiting
Urbana, Illinois, United States, 61801
Contact: Paula Bradley, RN, CCRP    217-326-0156    Paula.bradley2@carie.com   
Principal Investigator: Glenn Gordon, MD         
United States, Kansas
Cotton-O'Neil Clinical Research Center, 720 SW Lane St. Recruiting
Topeka, Kansas, United States, 66606
Contact: Heather Hirst    785-270-4881    hhirst@stormontvail.org   
Principal Investigator: Thomas Welton, MD         
United States, Maryland
Investigative Clinical Research, 612 Ridgely Avenue, Suite 401, Recruiting
Annapolis, Maryland, United States, 21401
Contact: Robin Doremus    410-224-4887    robin@icrmd.com   
Principal Investigator: Michael Epstein, MD         
Chevy Chase Clinical Research, 5550 Friendship Blvd. Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Erin Klepeis    301-652-5520    erin.klepeis@capitaldigestivecare.com   
Contact: Kathy Tracey    301-652-5520    kathy.tracey@capitaldigestivecare.com   
Principal Investigator: Robert Hardi, MD         
United States, Massachusetts
Commonwealth Clinical Studies, 189 Quincy St. Recruiting
Brockton, Massachusetts, United States, 02302-2926
Contact: Estelle Crowley    508-588-9900    ecrowley@gisdoc.com   
Principal Investigator: Mark Finkelstein, MD         
United States, Michigan
Center For Digestive Health Recruiting
Troy, Michigan, United States, 48098
Contact: Dawn Gedvilas    248-267-8485    dgedvilas@troygastro.com   
Principal Investigator: Sante Bologna, MD         
West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201 Recruiting
Wyoming, Michigan, United States, 49519
Contact: Jeanne Host    616-328-5319    hostjt@yahoo.com   
Principal Investigator: Allan Coates, DO         
United States, Missouri
Ehrhardt Clinical Research, LLC, 108 Congress Street Recruiting
Belton, Missouri, United States, 64012
Contact: Jody Ehrhardt    816-318-8488    jehrhardt@ecrtrials.com   
Principal Investigator: Michael Connor, MD         
United States, New Jersey
AGA Clinical Research Associates, Inc., 3205 Fire Road Recruiting
Egg Harbor Township, New Jersey, United States, 08324
Contact: Theresa Stevens    609-407-1220    theresa@atlanticgastro.com   
Principal Investigator: Barry Kaufman, MD         
Holy Name Medical Center, 718 Teaneck Road Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Marissa VanOrden    201-541-6384    vanorden@mail.holyname.org   
Principal Investigator: Mitchell Spinnel, MD         
United States, New York
Montefiore Medical Center, 111 East 210th Street Recruiting
Bronx, New York, United States, 10467
Contact: Mortadha Abd    347-671-8231      
Principal Investigator: Lawrence Brandt, MD         
Sub-Investigator: Olga Aroniadis, MD         
Sub-Investigator: Dana Lukin, MD         
North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111 Recruiting
Great Neck, New York, United States, 11021
Contact: Cailin Grant    516-387-3912    cgrant10@northwell.edu   
Principal Investigator: Keith Sultan, MD         
NYU Langone Long Island , 1000 Northern Boulevard, Suite 160 Recruiting
Great Neck, New York, United States, 11021
Contact: Susan Eugene, CRC    516-466-1051    susan.eugene@nyumc.org   
Principal Investigator: Robert Tepper, MD         
Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor Recruiting
New York, New York, United States, 10016
Contact: Betsy Moclair    917-409-3933    bmoclair@manhattanmedicalresearch.com   
Principal Investigator: Ian Lustbader, MD         
United States, North Carolina
University of North Carolina Center for inflammatory Bowel Diseases, CB 7080, 130 Mason Farm Road, 4151 Bioinformatics Bldg. Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mikki Sandridge    919-843-3873    ibdtrials@med.unc.edu   
Principal Investigator: Hans Herfarth, MD, PhD         
United States, Ohio
Ohio GI and Liver Institute, 2925 Vernon Place 100 Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Linda Magaw    513-872-4549    magaw@ccrstudy.com   
Principal Investigator: Alan Safdi, MD         
Ohio GI and Liver Institute Recruiting
Cincinnati, Ohio, United States, 45249
Contact: Amanda Snow    513-587-0410    asnow@ccrstudy.com   
Principal Investigator: Christopher South, MD         
United States, Tennessee
ClinSearch, 6035 Shallowford Road, Suite 109 Recruiting
Chatanooga, Tennessee, United States, 37421
Contact: Christy Sweet    423-698-4584    csweet@clinsearch-us.com   
Principal Investigator: Richard Krause, MD         
United States, Texas
Brooke Army Medical Center, 3551 Roger Brooke Drive Recruiting
Fort Sam Houston, Texas, United States, 78284
Contact: Sara S. Dela Cruz    210-916-3879    sara.s.delacruz.ctr@mail.mil   
Principal Investigator: John G. Gancayco, MD         
Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor Recruiting
Houston, Texas, United States, 77030
Contact: Guillermina Cruz    713-798-7616    gcruz@bcm.edu   
Principal Investigator: Jason Hou, MD         
University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234 Recruiting
Houston, Texas, United States, 77030
Contact: Lacie Ford    713-500-6654    Lacie.L.Ford@uth.tmc.edu   
Principal Investigator: Nirav Thosani, MD         
Spring Gastroenterology Associates, 8901 FM 1960 West Recruiting
Humble, Texas, United States, 77036
Contact: Moniba Rizvi    281-583-5000      
Principal Investigator: Ravi Moparty, MD         
DHAT Research Institute / Digestive Health Associates of Texas 3600 Shire Blvd, Suite 106 Recruiting
Richardson, Texas, United States, 75082
Contact: Matthew Burkemper, BA, CCRC    214-918-2170    matthew.burkemper@dhat.com   
Principal Investigator: Harry Sarles, Jr, MD         
Digestive Disease Center, 621 Camden Street, Suite 202 Recruiting
San Antonio, Texas, United States, 78215
Contact: Cynthia Gomez    210-614-1234 ext 435    cgomez@gastroconsa.com   
Principal Investigator: Ravi Ganeshappa, MD         
Tyler Research Institute, 1720 S. Beckham Recruiting
Tyler, Texas, United States, 75701
Contact: Deborah Nelson    903-595-5101    deborahn@dhstyler.com   
Principal Investigator: George DuVall, MD         
United States, Virginia
Gasteroenterology Associates of Northern Virgina, 3028 Javier Road Recruiting
Fairfax, Virginia, United States, 22031
Contact: Fred Lutu    703-698-8960    flutu@novagi.com   
Principal Investigator: Keith Mirkin, MD         
McGuire DVAMC, 1201 Broad Rock Boulevard Recruiting
Richmond, Virginia, United States, 23249
Contact: Lou Blackman    804-675-6789    lou.blackman@va.gov   
Principal Investigator: William Pandak, MD         
Australia, New South Wales
Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road Recruiting
Bankstown, New South Wales, Australia, 2200
Contact: Diane Redmond    61-2-9722-8794    Diane.Redmond@sswahs.nsw.gov.au   
Principal Investigator: Rupert Leong, MD         
Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road Recruiting
Concord, New South Wales, Australia, 2139
Contact: Melissa Kermeen    61-2-9767-5563 ext 61394    Melissa.Kermeen@sswahs.nsw.gov.au   
Principal Investigator: Rupert Leong, MD         
Nepean Hospital, Derby Street Recruiting
Kingswood, New South Wales, Australia, 2747
Contact: Dianne Stevens    61 2 4734 2435    dianne.stevens@health.nsw.gov.au   
Principal Investigator: Martin Weltman, MD         
Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St. Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Elise Sawyer    61-2-8738-4085    ibo.liverpool@sswahs.nsw.gov.au   
Principal Investigator: Watson Ng, MD         
Australia, Queensland
Department of Gastroenterology and Hepatology, Level 9, Ned Hanlon Building, Royal Brisbane and Women's Hospital Corner Butterfield Street and Bowen Bridge Street Recruiting
Herston, Queensland, Australia, 4029
Contact: Allison Brown    61-7-3646-4273    Allison.Brown2@health.qld.gov.au   
Contact: Madonna McIntyre    61-7-3646-4273    madonna.mcintyre@health.qld.gov.au   
Principal Investigator: Mariko Howlett, MD         
Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Sharyn Grossman    61-7-3163-8196    Sharyn.grossman@mater.org.au   
Principal Investigator: Timothy Florin, MD         
Australia, Victoria
Ballarat Health Services, Drummond St North Recruiting
Ballarat, Victoria, Australia, 3350
Contact: Carmel Goss    61-3-5320-4735    CarmelG@bhs.org.au   
Principal Investigator: MOHAMMED AL-ANSARI, MD         
Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Daniel Van Langenberg, MD    61-3-9094-9533    Daniel.van-Langenberg@monash.edu   
Principal Investigator: Daniel Van Langenberg, MD         
Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road Recruiting
Malvern, Victoria, Australia, 3144
Contact: Emily Coupar    +61 3 9508 1862    trials@mgiu.com.au   
Principal Investigator: A/Prof Henry Debinski, MD         
Canada, British Columbia
GI Research Institute, 770-1190 Hornby St Recruiting
Vancouver, British Columbia, Canada, V6Z 1K5
Contact: Mari Chris Colman    604-688-6332 ext 236    marichriscolman@gmail.com   
Principal Investigator: Brian Bressler, MD         
Discovery Clinical Services Ltd. 601 A Discovery St. Recruiting
Victoria, British Columbia, Canada, V8T 5G4
Contact: Lisa Warke    250-386-0023    lwarke@dresearch.ca   
Principal Investigator: Denis Petrunia, MD         
Canada, Ontario
Mount Sinai Hospital, 600 University Avenue, Suite 445 Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Shelley Mikolainis    416-586-4800 ext 4989    smikolainis@mtsinai.on.ca   
Principal Investigator: Hilary Steinhart, MD         
Canada, Quebec
Montreal General Hospital Digestive Lab Research Institute McGill University Health Center, 1650 Cedar Avenue C10.145 Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Melissa Diamond    514-934-1934 ext 44385    Melissa.diamond@mail.mcgill.ca   
Principal Investigator: Ernest Seidman, MD         
Sub-Investigator: Alain Bitton, MD         
Canada, Saskatchewan
University of Saskatchewan Royal University Hospital, 103 Hospital Drive IBD Clinical Trials Unit Rm 2658 Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Wendi Stumborg    306-655-0691    wendi.stumborg@saskatoonhealthregion.ca   
Principal Investigator: Sharyle Fowler, MD         
Czech Republic
Nemocnice Horovice, NH Hospital, a.s., Chirurgicke oddeleni, K Nemocnici 1106 Recruiting
Horovice, Czech Republic, 268 31
Contact: Zuzana Serclova, MD    00420 311 553 009    serclova@nemocnice-horovice.cz   
Principal Investigator: Zuzana Serclova, MD         
Gastroenterologie s.r.o., Manesova 646, Recruiting
Hradec Kralove, Czech Republic, 500 02
Contact: Milan Siroky, MD    00420 495 522 093    sirokydr@gmail.com   
Principal Investigator: Milan Siroky, MD         
HEPATO-GASTROENTEROLOGIE HK, s.r.o., Trida Edvarda Benese 1549/34 Recruiting
Hradec Kralove, Czech Republic, 50012
Contact: Tomas Vanasek, MUDr. / PhD.    00420 495218475    tomas.vanasek@hepato-gastro.com   
Principal Investigator: Tomas Vanasek, MUDr. / PhD.         
IBD centrum / ISCARE IVF a.s., Jankovcova 1569/2c Recruiting
Praha, Czech Republic, 17000
Contact: Milan Lukas, MD, PhD    00420 234770292    milan.lukas@email.cz   
Principal Investigator: Milan Lukas, MD, PhD         
ARTROSCAN, s.r.o., Gastroenterologicka ambulance, Trebovicka, 722 00 Ostrava Recruiting
Trebovice, Czech Republic
Contact: Vit Smajstrla    00420 596 938 949    bormed1@volny.cz   
Principal Investigator: Vit Smajstrla, MD         
Israel
Bnaizion Medical Center, Golomb 47 Recruiting
Haifa, Israel, 31048
Contact: Leonid Shpoker    972-505799509    Leonid.Shpoker@B-Zion.org.il   
Principal Investigator: Tova Rainis, MD         
The E. Wolfson Medical Center, 62 Halohamim Str. Recruiting
Holon, Israel, 58100
Contact: Orit Shevah    972 3 5028482    oritsh@wolfson.health.gov.il   
Principal Investigator: Yona Avni, MD         
Shaare Zedek Medical Center, Beith Street Recruiting
Jerusalem, Israel, 91031
Contact: Chava Kaniel    972-545 847100    chavak@szmc.org.il   
Principal Investigator: Eran Goldin, MD         
Ein Karem Medical Center, Kiryat Hadassah Recruiting
Jerusalem, Israel, 91120
Contact: Vera Yitshak    972 2 6777595    verapi@hadassah.org.il   
Principal Investigator: Eran Israeli, MD         
Meir, 59 Tchemacovsky St Recruiting
Kfar-Saba, Israel, 44281
Contact: Orly Hanin    +1 972-9-7471017    orly.hanin@clalit.org.il   
Principal Investigator: Fred Konikoff, MD         
Galilee Medical Center, P.O.B. 21 Recruiting
Nahariya, Israel, 1210001
Contact: Florencia Kanelo    +972 052-5554785    florenciak@clalit.org.il   
Principal Investigator: Wisam Sbeit, MD         
Holy Family Hospital, Namsawi St. POB 8 Recruiting
Nazareth, Israel, 16100
Contact: Rami Ghantous    +972 547 748258    ramighantous@yahoo.com   
Principal Investigator: Rifaat Safadi, MD         
RMC Beilinson Hospital, 39 Jabotinsky Street Recruiting
Petach-Tikva, Israel, 49100
Contact: Inbal Grossman    972-3-6068194    Inbalgr3@clalit.org.il   
Principal Investigator: Irit Avni-Biron, MD         
Sourasky Medical Center, 6 Weizman Street Recruiting
Tel Aviv, Israel, 64239
Contact: Smadar Baram    +972 3 697-3011    smadarbar@tlvmc.gov.il   
Principal Investigator: Sigal Fishman, MD         
Assaf HaRofeh Medical Center, Gastroenterology Department, Harofeh Medical Center Recruiting
Tsrifin, Israel, 70300
Contact: Rona Lobel    972 8 977 9655    ronal@asaf.health.gov.il   
Principal Investigator: Haim Shirin, MD         
New Zealand
Shakespeare Specialist Group, North Shore, Suite 3, 181 Shakespeare Road, Milford Takapuna Recruiting
Auckland, New Zealand, 0620
Contact: Ian Wallace, MD    64-9-489-2384    iwallace@xtra.co.nz   
Principal Investigator: Ian Wallace, MD         
Clinical Trials Unit, Tauranga Hospital, Tauranga Recruiting
Bay of Plenty, New Zealand, 3112
Contact: Adrian Claydon, MD    64 7 578 1208      
Principal Investigator: Sundaram Veerappan, MD         
Christchurch Hospital Recruiting
Christchurch, New Zealand, 4710
Contact: RICHARD GEARRY, MD    +6433640135    richard.gearry@cdhb.health.NZ   
Principal Investigator: RICHARD GEARRY, MD         
Gastroenterology Unit, Southern District Health Board, 201 Great King Street, Recruiting
Dunedin, New Zealand, 9054
Contact: Merrilee Williams    +64-3-474-0999 ext 8518    merrilee.williams@southerndhb.govt.nz   
Principal Investigator: Michael Schultz, MD         
Department of Gastroenterology,Waikato Hospital Recruiting
Hamilton, New Zealand, 3240
Contact: Sherryl Hayett    64-7-839-8899 ext 23018    Sherryl.Hayett@waikatodhb.health.nz   
Principal Investigator: James Brooker, MD         
Poland
NZOZ Specjalistyczne Centrum Gastrologii GASTROMED Wiejska 81 Recruiting
Bialystok, Poland, 15-351
Contact: Monika Baldowska    +48 85 733 6090      
Principal Investigator: Jacek Romatowski, Dr n. med.         
SP ZOZ MSWiA w Gdańsku, Oddział Gastroenterologiczny, ul. Kartuska 4/6 Recruiting
Gdańsk, Poland, 80-104
Contact: Agnieszka Klufczynska, MD    : +48 58 309 834    agnieszka.klufczynska@op.pl   
Principal Investigator: Grażyna Piotrowicz, MD, PhD         
UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA Specjalistyczne Centrum Medyczne Sp. z o.o. Kluczborska 15 Recruiting
Krakow, Poland, 31-271
Contact: Monika Huza Chodacka    +48 697 174 075    unicardia@interia.pl   
Principal Investigator: Zbigniew Hebzda, Dr n. med.         
Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny Żołnierska 18 Recruiting
Olsztyn, Poland, 10-561
Contact: Anna Wos    +48 89 538 6475    annawos1982@gmail.com   
Principal Investigator: Tomasz Arlukowicz, Dr n. med.         
ENDOSKOPIA sp. z o.o. B. Chrobrego 6/8 Recruiting
Sopot, Poland, 81-756
Contact: Dariusz Kleczkowski    +48602601103    szach999@wp.pl   
Principal Investigator: Marek Horynski, Dr n. med.         
EuroMedis sp. z.o.o., ul. Powstanców Wielkopolskich 33a Recruiting
Szczecin, Poland, 70-111
Contact: Agata Ciepiela    +48 91 813 6322    agata.ciepiela@euromedis.pl   
Principal Investigator: Wojciech Marlicz, MD         
Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. Wigury 19 Recruiting
Todz, Poland, 90-302
Contact: Agnieszka Pacholska, MSc    +48 42 254 9624      
Principal Investigator: Maria Wisniewska-Jarosinska, Dr n. med.         
"GASTROMED" Kopon, Zmudzinski i wspolnicy sp. j., Specjalistyczne Centrum Gastroskopii i Endoskopii, Specjalistyczne Gabinety Lekarskie Grudziadzka 11 Recruiting
Torun, Poland, 87-100
Contact: Daria Kriks    +48790800856    gastromedtrials@gmail.com   
Principal Investigator: Adam Kopon, Dr n. med.         
Centralny Szpital Kliniczny MSW w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii Woloska 137 Recruiting
Warszawa, Poland, 02-507
Contact: Beata Stepien       beatastepien9@op.pl   
Principal Investigator: Grzyna Rydzewska, MD, PhD         
ARS MEDICA s.c. Rybak Maria, Rybak Zbigniew, Powstancow Slaskich 56A/2 Recruiting
Wroclaw, Poland, 53-333
Contact: Jadwiga Lapinska, MD, PhD       lapinskajadwiga@gmail.com   
Principal Investigator: Barbara Wozniak-Stolarska, MD, PhD         
Serbia
: Clinic for Gastroenterology and Hepatology, Clinical Center of Serbia Koste Todorovica 2 Recruiting
Belgrade, Serbia, 11000
Contact: Ivana Jovicic, MD    +38164 119 87 75    05ivana1962@gmail.com   
Principal Investigator: Srdjan Djuranovic, MD         
Clinical Department of Gastroenterology and Hepatology, Clinic for Internal Diseases, Clinical Hospital Center Zvezdara Dimitrija Tucovica 161 Recruiting
Belgrade, Serbia, 11000
Contact: Marijana Protic, MD    +38163 345 985    marijana.n.protic@gmail.com   
Principal Investigator: Petar Svorcan, MD         
Department of Gastroenterology and Hepatology, Clinical Hospital Center Zemun Vukova 9 Recruiting
Belgrade, Serbia, 11080
Contact: Aleksandar Pavlovic, MD    +38164 2580244    aleksandar_pavlovic77@yahoo.com   
Principal Investigator: Predrag Dugalic, MD         
: Center for Gastroenterohepatology, Clinic for Internal Medicine, Clinical Center of Kragujevac Zmaj Jovina 30 Recruiting
Kragujevac, Serbia, 34000
Contact: Ziva Zivic, MD    +38160 333 77 83    zzzivic@gmail.com   
Principal Investigator: Natasa Zdravkovic-Petrovic, MD         
: Clinic of Gastroenterology and Hepatology, Clinical Center of Vojvodina Hajduk Veljkova 1 Recruiting
Novi Sad, Serbia, 21000
Contact: Tatiana Jocic, MD    +38163 80 50 381    tajocic@gmail.com   
Principal Investigator: Dragomir Damjanov, MD         
Slovakia
Breznianske centrum gastroenterologie, s.r.o. Banisko 1 Recruiting
Brezno, Slovakia, 97701
Contact: Martin Tkacik    +421 903 886 992    martintkacik@yahoo.co.uk   
Principal Investigator: Jozef Tkacik, MD         
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
Study Director: Ira N Kalfus, MD RedHill Biopharma
Principal Investigator: David Y. Graham, MD Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
  More Information

Additional Information:
Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT01951326     History of Changes
Other Study ID Numbers: RHB-104-01
Study First Received: September 19, 2013
Last Updated: March 22, 2017

Keywords provided by RedHill Biopharma Limited:
Crohn's Disease
moderate to severe
remission
MAP
antibiotic

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on March 24, 2017