DDrare: Database of Drug Development for Rare Diseases

A fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine (DrugBank: Rifabutin, Clofazimine, Clarithromycin)

ID	Disease name (Link within this page)	Number of trials
96	Crohn disease	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03009396 (ClinicalTrials.gov)	March 18, 2017	26/12/2016	Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease	An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study	Crohn Disease	Drug: RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine	RedHill Biopharma Limited	NULL	Completed	18 Years	76 Years	All	54	Phase 3	United States;Canada;Czechia;Israel;New Zealand;Poland;Serbia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03009396
(ClinicalTrials.gov)

March 18, 2017

26/12/2016

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

An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study

Crohn Disease

Drug: RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine

RedHill Biopharma Limited

NULL

Completed

18 Years

76 Years

All

Phase 3

United States;Canada;Czechia;Israel;New Zealand;Poland;Serbia