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

NCT04616924 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

  • Pulmonary Mycobacterium Avium Complex Infection
  • Bronchiectasis
  • Lung Diseases

Interventions

DRUG

RHB-204

RHB-204

DRUG

Placebo

Matching placebo to RHB-204

Sponsors & Collaborators

  • RedHill Biopharma Limited

    lead INDUSTRY

Principal Investigators

  • Kevin L. Winthrop, MD, MPH · Oregon Health and Science University

  • June L Almenoff, MD, PhD · RedHill Biopharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-08-28
Completion
2023-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04616924 on ClinicalTrials.gov