Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 136
Summary
- Conditions
- Cystic Fibrosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Double-blind, randomized, parallel groups and placebo-controlled trial.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Patients will be randomly assigned to take either the active drug (fenretinide capsule) or a matching inactive placebo (inactive capsule).Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF. All patients will remain on their CF standard-of-care treatments over the trial duration. The goal for the treatme...
An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF. All patients will remain on their CF standard-of-care treatments over the trial duration. The goal for the treatment with LAU-7b in CF is to preserve lung function by reducing the persistent inflammation in the lung and to improve its capacity to defend against resistant bacteria such as Pseudomonas aeruginosa. The treatment regimen will consist of 6 consecutive "dosing cycles" of 21 days each, spaced by study drug-free periods of 7 days. A total of 136 eligible adult patients with CF will be randomized to receive 300 mg LAU-7b or placebo in a 1:1 ratio. The participation in the study will last about 7 months.
Tracking Information
- NCT #
- NCT03265288
- Collaborators
- Cystic Fibrosis Foundation
- Investigators
- Study Chair: Larry C Lands, MD PhD McGill Uinversity Health Centre Study Chair: Michael W Konstan, MD Rainbow Babies and Children's Hospital/ University Hospitals Cleveland Medical Center
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