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

PHASE3CompletedINTERVENTIONAL
Enrollment

331

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

May 31, 2018

Study Completion Date

August 31, 2019

Conditions
Crohn's Disease
Interventions
DRUG

RHB-104

95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine

DRUG

Placebo

5 placebo capsules administered orally BID

Trial Locations (103)

1432

"UMHAT Sv. Ivan Rilski EAD; Clinic of Gastroenterology, 15, Akad. Ivan Geshov Blvd.,", Sofia

1784

ACIBADEM CITY CLINIC UNIVERSITY HOSPITAL EOOD, Oncology Center, Clinic of Gastroenterology, 66 A, Tsarigradsko shosse Blvd, Sofia

2139

Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road, Concord

2170

Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St., Liverpool

2200

Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road, Bankstown

2747

Nepean Hospital, Derby Street, Kingswood

3112

Clinical Trials Unit, Tauranga Hospital,, Tauranga

3128

Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street, Box Hill

3144

Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road, Malvern

3240

Department of Gastroenterology,Waikato Hospital, Hamilton

3350

Ballarat Health Services, Drummond St North, Ballarat

4002

"MHAT Sv. Karidad EAD, Department of Internal Medicine / Gastroenterology, endocrinology and metabolic disorders, 23А, Nikola Vaptsarov Blvd", Plovdiv

4029

Department of Gastroenterology and Hepatology, Level 9, Ned Hanlon Building, Royal Brisbane and Women's Hospital Corner Butterfield Street and Bowen Bridge Street, Herston

4101

Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace, South Brisbane

4710

Christchurch Hospital, Christchurch

8800

"MHAT Hadzhi Dimitar OOD, Department of Internal Medicine / Gastroenterology and Endocrinology, 5, Dimitar Pehlivanov str.", Sliven

9020

"DCC Mladost-M Varna OOD, office 528 V, 15, Republika Blvd.", Varna

9054

Gastroenterology Unit, Southern District Health Board, 201 Great King Street,, Dunedin

10016

Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor, New York

10467

Montefiore Medical Center, 111 East 210th Street, The Bronx

11000

: Clinic for Gastroenterology and Hepatology, Clinical Center of Serbia Koste Todorovica 2, Belgrade

Clinical Department of Gastroenterology and Hepatology, Clinic for Internal Diseases, Clinical Hospital Center Zvezdara Dimitrija Tucovica 161, Belgrade

11021

North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111, Great Neck

NYU Langone Long Island , 1000 Northern Boulevard, Suite 160, Great Neck

11080

Department of Gastroenterology and Hepatology, Clinical Hospital Center Zemun Vukova 9, Belgrade

13000

EGK s.r.o., Sanatorium sv. Anny, Gastroenterologicke oddeleni, Lucni 7a/2776,, Prague

16100

Holy Family Hospital, Namsawi St. POB 8, Nazareth

17000

IBD centrum / ISCARE IVF a.s., Jankovcova 1569/2c, Prague

20815

Chevy Chase Clinical Research, 5550 Friendship Blvd., Chevy Chase

21000

: Clinic of Gastroenterology and Hepatology, Clinical Center of Vojvodina Hajduk Veljkova 1, Novi Sad

21401

Investigative Clinical Research, 612 Ridgely Avenue, Suite 401,, Annapolis

22031

Gasteroenterology Associates of Northern Virgina, 3028 Javier Road, Fairfax

23249

McGuire DVAMC, 1201 Broad Rock Boulevard, Richmond

27599

University of North Carolina Center for inflammatory Bowel Diseases, CB 7080, 130 Mason Farm Road, 4151 Bioinformatics Bldg., Chapel Hill

30033

Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550, Decatur

30060

Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300, Marietta

31048

Bnaizion Medical Center, Golomb 47, Haifa

32127

Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110, Port Orange

32802

Endoscopic Research, Inc., 1817 North Mills Avenue, Orlando

33180

Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330, Aventura

33319

Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111, Lauderdale Lakes

33765

Clinical Research of West Florida, Clearwater

34000

: Center for Gastroenterohepatology, Clinic for Internal Medicine, Clinical Center of Kragujevac Zmaj Jovina 30, Kragujevac

34102

Gastroenterology Group of Naples, 1064 Goodlette Road, Naples

34653

Advanced Research Institute Inc., 7114 Congress Street, New Port Richey

37421

ClinSearch, 6035 Shallowford Road, Suite 109, Chattanooga

44281

Meir, 59 Tchemacovsky St, Kfar Saba

45219

Ohio GI and Liver Institute, 2925 Vernon Place 100, Cincinnati

45249

Ohio GI and Liver Institute, Cincinnati

48098

Center For Digestive Health, Troy

49100

RMC Beilinson Hospital, 39 Jabotinsky Street, Petah Tikva

49519

West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201, Wyoming

50012

HEPATO-GASTROENTEROLOGIE HK, s.r.o., Trida Edvarda Benese 1549/34, Hradec Králové

58100

The E. Wolfson Medical Center, 62 Halohamim Str., Holon

60612

Rush University Medical Center, Chicago

61801

The Carle Foundation, 611 West Park Street, Urbana

64012

Ehrhardt Clinical Research, LLC, 108 Congress Street, Belton

64239

Sourasky Medical Center, 6 Weizman Street, Tel Aviv

66606

Cotton-O'Neil Clinical Research Center, 720 SW Lane St., Topeka

70300

Assaf HaRofeh Medical Center, Gastroenterology Department, Harofeh Medical Center, Be’er Ya‘aqov

75082

DHAT Research Institute / Digestive Health Associates of Texas 3600 Shire Blvd, Suite 106, Richardson

75701

Tyler Research Institute, 1720 S. Beckham, Tyler

77030

Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor, Houston

University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234, Houston

77036

Spring Gastroenterology Associates, 8901 FM 1960 West, Humble

78215

Digestive Disease Center, 621 Camden Street, Suite 202, San Antonio

78284

Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston

82606

Univerzitna nemocnica Bratislava - Nemocnica Ružinov, V. Interná klinika LFUK a UNB, Gastroenterologické a hepatologické oddelenie, Ruzinovska 6, Bratislava

85710

Del Sol Research Management, 850 N Knob Road, Tucson

90638

Medvin Clinical Research, 15627 Imperial Highway,, La Mirada

91031

Shaare Zedek Medical Center, Beith Street, Jerusalem

91120

Ein Karem Medical Center, Kiryat Hadassah, Jerusalem

92801

Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303, Anaheim

93003

Ventura Clinical Trials, 1835 Knoll Drive, Ventura

94070

Digestive Care Associates, Inc., 1000 Laurel St., San Carlos

97701

Breznianske centrum gastroenterologie, s.r.o. Banisko 1, Brezno

1210001

Galilee Medical Center, P.O.B. 21, Nahariya

06518

Medical Research Center of Connecticut, LLC, Hamden

02302-2926

Commonwealth Clinical Studies, 189 Quincy St., Brockton

08324

AGA Clinical Research Associates, Inc., 3205 Fire Road, Egg Harbor

07666

Holy Name Medical Center, 718 Teaneck Road, Teaneck

V8T 5G4

Discovery Clinical Services Ltd. 601 A Discovery St., Victoria

M5G 1X5

Mount Sinai Hospital, 600 University Avenue, Suite 445, Toronto

H3G 1A4

Montreal General Hospital Digestive Lab Research Institute McGill University Health Center, 1650 Cedar Avenue C10.145, Montreal

S7N 0W8

University of Saskatchewan Royal University Hospital, 103 Hospital Drive IBD Clinical Trials Unit Rm 2658, Saskatoon

268 31

Nemocnice Horovice, NH Hospital, a.s., Chirurgicke oddeleni, K Nemocnici 1106, Hořovice

500 02

Gastroenterologie s.r.o., Manesova 646,, Hradec Králové

722 00

ARTROSCAN, s.r.o., Gastroenterologicka ambulance, 5114 Trebovicka, Ostrava, Třebovice

401 13

Krajska zdravotni, a.s., Masarykova nemocnice o.z. Gastroenterologie, Socialni pece 3316/12A, Ústí nad Labem

0620

Shakespeare Specialist Group, North Shore, Suite 3, 181 Shakespeare Road, Milford Takapuna, Auckland

15-351

NZOZ Specjalistyczne Centrum Gastrologii GASTROMED Wiejska 81, Bialystok

80-104

SP ZOZ MSWiA w Gdańsku, Oddział Gastroenterologiczny, ul. Kartuska 4/6, Gdansk

31-271

UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA Specjalistyczne Centrum Medyczne Sp. z o.o. Kluczborska 15, Krakow

90-302

Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. Wigury 19, Lodz

10-561

Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny Żołnierska 18, Olsztyn

81-756

ENDOSKOPIA sp. z o.o. B. Chrobrego 6/8, Sopot

70-111

EuroMedis sp. z.o.o., ul. Powstanców Wielkopolskich 33a, Szczecin

87-100

"GASTROMED Kopon, Zmudzinski i wspolnicy sp. j., Specjalistyczne Centrum Gastroskopii i Endoskopii, Specjalistyczne Gabinety Lekarskie Grudziadzka 11", Torun

02-507

Centralny Szpital Kliniczny MSW w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii Woloska 137, Warsaw

53-333

ARS MEDICA s.c. Rybak Maria, Rybak Zbigniew, Powstancow Slaskich 56A/2, Wroclaw

851 07

Univerzitná nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda Gastroenterologická klinika SZU a UNB Antolská 11, Bratislava

036 01

PIGEAS s.r.Prieložtek 1, o.,, Martin

949 01

KM Management spol. s.r.o., Gastroenterologické a hepatologické centrum Nitra, Špitálska 13, Nitra

All Listed Sponsors
lead

RedHill Biopharma Limited

INDUSTRY

NCT01951326 - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease | Biotech Hunter | Biotech Hunter