Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

March 18, 2017

Primary Completion Date

November 13, 2018

Study Completion Date

August 19, 2019

Conditions
Crohn Disease
Interventions
DRUG

RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)

For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks

Trial Locations (24)

3240

Waikato Hospital, Department of Gastroenterology, Level B1, Menzies Building, Pembroke Street, Hamilton

11000

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

11080

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

20815

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

30060

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

34000

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

37421

ClinSearch 6035 Shallowford Road Suite 109, Chattanooga

44281

Meir Medial Center, 59 Tchemacovsky St., Kfar Saba

66606

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

80011

Christchurch Hospital, 2 Riccarton Rd., Christchurch

91120

Gastroenterology Institute, Division of Medicine, Hadassah - Hebrew University Medical Center POB 12000, Jerusalem

94070

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

1834111

Ha'Emek Medical Center, Institute of Gastroenterology and Liver diseases, 21 Yitshak Rabin Boulevard, Afula

02302-2926

Commonwealth Clinical Studies, 189 Quincy St., Brockton

V8T 5G4

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

500 02

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

500 12

Hepato-Gastroenterologie HK, s.r.o., Hradecka poliklinika III Trida Edvarda Benese 1549/34, Hradec Králové

15-351

NZOZ Specjalistyczne Centrum Gastrologii GASTROMED, Wiejska 81, Bialystok

80-104

Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW 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

10-561

Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny, Zolnierska 18, Olsztyn

70-111

EuroMedis sp. z.o.o., Al. Powstancow Wielkopolskich 33a, Szczecin

02-507

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

53-333

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

All Listed Sponsors
lead

RedHill Biopharma Limited

INDUSTRY

NCT03009396 - Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease | Biotech Hunter | Biotech Hunter