At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 54 enrolled
Drug / intervention
RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)drug
Likely dose
RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) for Crohn Disease. Completed, enrolled 54 participants across 24 sites in 7 countries.
Detailed Summary
An open label extension to the RHB-104-01 Study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesCanada, Czechia, Israel, New Zealand, Poland, Serbia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartMar 2017
Primary CompletionNov 2018
Study CompletionAug 2019
TodayJul 2026
First PostedJan 4, 2017
Enrollment StartMar 18, 2017
Primary CompletionNov 13, 2018
Study CompletionAug 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.5 years ago
Interventions
RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)drug
For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks