Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant

Recruiting Phase 3 Interventional Study
Pre-Bronchiolitis Obliterans Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Renovion, Inc. · Industry
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About This Trial
The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: * Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant * To evaluate the effectiveness of ARINA-1 on improving…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Bilateral lung transplant \>12 months from the time of Visit 1 / Randomization 2. Age 18-75 years old at the time of consent 3. Routinely followed at enrolling site 4. Willing and able to comply with visit schedule and at-home requirements 5. 10-24% decrease in FEV1 from the …
Contacts

Carolyn Durham, PhD

919-240-7034

info@renovion.com

CONTACT

Will Anderson

919-240-7034

info@renovion.com

CONTACT