drugset / Trial / NCT04616924

RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease

NCT04616924

Phase 3 Terminated 12 enrolled RedHill Biopharma Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2020-12-01
Primary completion
2023-08-28
Completion
2023-08-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 158.3 mg
Subject Clofazimine Small molecule 13.3 mg
Subject Rifabutin Small molecule 40 mg