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Withdrawn Phase 2 Interventional

Study to Determine the Efficacy&Safety of ARV-1801(ACG-701) for the Treatment of Cystic Fibrosis Pulmonary Exacerbations

ClinicalTrials.gov ID: NCT05641298

Public ClinicalTrials.gov record NCT05641298. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 2:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, DB, Placebo-controlled Study to Determine the Efficacy, Safety and PK Profile of ARV-1801 in Combination With Optimized Background Therapy for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the efficacy and safety of an oral ARV-1801(ACG-701) plus optimized background therapy (OBT) compared to oral placebo plus OBT, each administered for 14 days, in the treatment of participants with Cystic Fibrosis-related pulmonary exacerbations (PEx).

Study identification

NCT ID
NCT05641298
Recruitment status
Withdrawn
Study type
Interventional
Phase
Phase 2
Lead sponsor
Aceragen
Industry
Enrollment
Not listed

Conditions and interventions

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 10, 2023 (Actual)
Primary completion
Sep 2023 (Estimated)
Completion
Sep 2023 (Estimated)
Last update posted
Jul 19, 2023

2023

United States locations

U.S. sites
25
U.S. states
19
U.S. cities
25
Facility City State ZIP Site status
University of Florida Gainesville Florida 32610 —
Central Florida Pulmonary Group Orlando Florida 32803 —
Nemours Children's Health - Pensacola Pensacola Florida 32514 —
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 —
Cystic Fibrosis Center of Chicago Chicago Illinois 60093 —
Cystic Fibrosis Center of Chicago Northfield Illinois 60093 —
Riley Hospital for Children Indianapolis Indiana 46202 —
University of Kansas Medical Center Kansas City Kansas 66160 —
University Of Louisville Louisville Kentucky 40202 —
Maine Medical Center Portland Maine 04102 —
Johns Hopkins University Baltimore Maryland 21287 —
University of Michigan, Michigan Medicine Ann Arbor Michigan 48109 —
Washington University School of Medicine St Louis Missouri 63114 —
UNMC-Nebraska CF Pediatric Center Omaha Nebraska 68114 —
Gunnar H. Esiason Adult Cystic Fibrosis Center Morristown New Jersey 07960 —
New York Medical College Hawthorne New York 10532 —
University of Rochester Medical Center Strong Memorial Rochester New York 14642 —
Rainbow Babies and Children's Hospital/Cleveland Medical Center Cleveland Ohio 44106 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15224 —
Medical University of South Carolina Charleston South Carolina 29425 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Cook Children's Health Care System Fort Worth Texas 76104 —
The University of Health Science Center at Tyler Tyler Texas 75708 —
Providence Medical Research Center Spokane Washington 99204 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05641298, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 19, 2023 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05641298 live on ClinicalTrials.gov.

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