RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bronchiectasis
- Lung Diseases
- Pulmonary Mycobacterium Avium Complex Infection
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
A 2-part multi-center, Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of RHB-204 in adult subjects with underlying nodular bronchiectasis and documented MAC lung infection. The primary efficacy endpoint evaluates sputum culture convers...
A 2-part multi-center, Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of RHB-204 in adult subjects with underlying nodular bronchiectasis and documented MAC lung infection. The primary efficacy endpoint evaluates sputum culture conversion evaluated at Month 6 (and defined as at least 3 prior consecutive negative monthly sputum cultures at Month 6). Subjects remain on study drug in Part 2 until Month 16. Patient reported outcomes and durability of microbiological response will be assessed at Month 6 and Month 19 (3 months post-completion of treatment).
Tracking Information
- NCT #
- NCT04616924
- Collaborators
- Not Provided
- Investigators
- Study Director: Kevin L. Winthrop, MD, MPH Oregon Health and Science University Study Chair: June L Almenoff, MD, PhD RedHill Biopharma, Inc.
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