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NCT03009396 · ClinicalTrials.gov registry record · Phase 3
Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease
A Phase 3 study, sponsored by RedHill Biopharma Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
NCT03009396: Completed Phase 3 study, sponsored by RedHill Biopharma Limited.
NCT03009396 is a Phase 3 study that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 54 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03009396, a Phase 3 study, has completed, sponsored by RedHill Biopharma Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
Study Summary
An open label extension to the RHB-104-01 Study.
Primary Outcome
The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points. Lower CDAI scores indicate a better outcome.
Interventions
- DRUG RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-03-18 |
| Est. Completion | 2019-08-19 |
| Phase | Phase 3 |
What the finished NCT03009396 record still lists
NCT03009396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) is the first listed.
NCT03009396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03009396 about?
NCT03009396 is a clinical study titled "Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease". An open label extension to the RHB-104-01 Study.
What is the current status of trial NCT03009396?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2017-03-18. Estimated completion is 2019-08-19.
What interventions are being tested in trial NCT03009396?
The interventions under investigation include: RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) (DRUG).
Who is sponsoring clinical trial NCT03009396?
This trial is sponsored by RedHill Biopharma Limited, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03009396's enrollment target sits among peer trials
54 1838th of 2000 higher than 162 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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