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Clinical Trial Finder
Anti-Infective Enrolling
Study of ARV-1801 (ACG-701) for the treatment of pulmonary exacerbations in CF patients 12 years of age or older. (Aceragen ARV-1801 )
This study will evaluate the efficacy and safety of the study drug ARV-1801, an oral drug intended to treat infections in the lung. The study also will evaluate how the body processes the drug.
This study will be randomized and placebo controlled. This means that some participants will receive ARV-1801 in addition to optimized background therapy, and others will receive placebo in addition to optimized background therapy. Optimized background therapy is a treatment that addresses other aspects of exacerbations, such as increased airway clearance and/or antibiotics. Researchers will test to see if ARV-1801 in addition to optimized background therapy is superior to background therapy alone. Participants will fill out an electronic symptom diary every day of the study.
This study may require sputum specimens, pulmonary function testing, and lab draws.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants in this study will have been just diagnosed with a pulmonary exacerbation.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
28 days -
Number of Study Visits:
5
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Aceragen -
Study Drugs:
Study Sites
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Enrolling Soon
Florida
All Children's Hospital, St. Petersburg, FL 33701
Contact
Diana Hodge
Phone: +1 (727) 767-6881
Email: dhodge6@jhmi.edu
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Enrolling Soon
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Kathleen Summo
Phone: +1 (407) 841-1100
Email: ksummo@cfpulmonary.com
-
Enrolling Soon
Florida
University of Florida, Gainesville, FL 32610
Contact
Alexa Smith
Phone: +1
Email: alexa.howell@ufl.edu
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Enrolling Soon
Florida
University of Miami, Miami, FL 33136
Contact
Ylber Whitaker
Phone: +1 (305) 243-5545
Email: yiw2@miami.edu
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Enrolling Soon
Florida
Nemours Children's Health - Pensacola, Pensacola, FL 32514
Contact
Rebecca Davis
Phone: +1 (850) 473-4553
Email: Rebecca.Davis@nemours.org
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Enrolling Soon
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
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Enrolling Soon
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
-
Enrolling Soon
Kentucky
University of Louisville, Louisville, KY 40202
Contact
Melissa Thomas
Phone: +1
Email: mcthom12@louisville.edu
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Enrolling Soon
Maine
Maine Medical Center, Portland, ME 04102
Contact
Harmony Renna
Phone: +1 (207) 662-5917
Email: Harmony.Renna@mainehealth.org
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Enrolling Soon
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
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Enrolling Soon
Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
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Enrolling Soon
Nebraska
University of Nebraska Medical Center, Omaha, NE 68114
Contact
Jill Fahner
Phone: +1 (402) 836-9749
Email: Jill.fahner@unmc.edu
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Enrolling Soon
New Jersey
Morristown Medical Center , Morristown, NJ 07960
Contact
Debra Connolly
Phone: +1 (973) 971-7293
Email: Debra.Connolly@atlantichealth.org
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Enrolling Soon
New York
University of Rochester Medical Center Strong Memorial, Rochester, NY 14642
Contact
Barbara Johnson
Phone: +1 (585) 276-4123
Email: Barbara_Johnson@URMC.Rochester.edu
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Enrolling Soon
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
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Enrolling Soon
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
Contact
Kelly Thornton
Phone: +1 (513) 636-0604
Email: Kelly.Thornton@cchmc.org
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Enrolling Soon
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
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Enrolling Soon
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
Contact
Participant Contact Oklahoma Cystic Fibrosis Center
Phone: +1 (405) 271-6216
Email: cfresearchteam@ouhsc.edu
-
Enrolling Soon
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
-
Enrolling Soon
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
-
Enrolling Soon
Tennessee
Vanderbilt Children's Hospital, Nashville, TN 37232
Contact
Brijesh Patel
Phone: +1 (615) 343-4865
Email: brijesh.patel@vumc.org
-
Enrolling Soon
Texas
Cook Children's Medical Center, Fort Worth, TX 76104
Contact
Jill Finto
Phone: +1 (682) 885-2672
Email: jill.finto@cookchildrens.org
-
Enrolling Soon
Texas
University of Texas Health Center at Tyler, Tyler, TX 75708
Contact
Debbie Fielder
Phone: +1 (903) 877-7753
Email: debbie.fielder@uthct.edu
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Enrolling Soon
Washington
Providence Medical Group, Cystic Fibrosis Clinic, Spokane, WA 99204
Contact
Joan Milton
Phone: +1 (509) 474-4323
Email: joan.milton@providence.org
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit -
Pseudomonas Status:
Positive Respiratory Cultures Required
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants in this study will have been just diagnosed with a pulmonary exacerbation.
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