Page Title
Clinical Trial Finder
Nutritional-GI Enrolling
Study to evaluate ANG003 in people with CF ages 12 and older (Anagram ANG003-25-201)
This study will assess the safety and effectiveness of ANG003, a pancreatic enzyme replacement therapy (also known as “enzymes” or “enzyme therapy”) to see whether it works as well as the approved enzyme therapy Creon.
This is a randomized, active-controlled study. Study participants will start the study on Creon and then be selected at random to different groups, or study arms. Some participants will receive one of two doses of the study drug, ANG003; some will continue Creon; and some will not take enzymes for a total of about 4-7 days. Researchers will monitor participants for adverse events, changes in fat absorption, and changes in stool.
This study may include stool collections and blood 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:
30% or greater
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants will have a diagnosis of severe exocrine pancreatic insufficiency and will be on a stable dose of pancreatic enzyme replacement therapy (PERT).
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
3 months -
Number of Study Visits:
6
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Anagram Therapeutics -
Study Drugs:
Study Sites
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Enrolling Soon
California
Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033
Contact
Lynn Fukushima
Phone: +1 (323) 442-8522
Email: lynn.fukushima@med.usc.edu
-
Enrolling Soon
California
Long Beach Memorial Medical Center, Long Beach, CA 90806
Contact
Angelica Rodriguez
Phone: +1
Email: ARodriguez9@memorialcare.org
-
Enrolling Soon
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2517
Email: wilsona@njhealth.org
-
Enrolling Soon
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Desiree Serr
Phone: +1 (407) 303-7192
Email: desiree.serr1@adventhealth.com
-
Enrolling Soon
Florida
University of Florida, Gainesville, FL 32610
Contact
Alexa Smith
Phone: +1
Email: alexa.howell@ufl.edu
-
Enrolling Soon
Iowa
University of Iowa, Iowa City, IA 52242
Contact
Mary Teresi
Phone: +1 (319) 384-7546
Email: mary-teresi@uiowa.edu
-
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 Kentucky, Lexington, KY 40506
Contact
Chase Whitaker
Phone: +1 (859) 218-4810
Email: chase.whitaker@uky.edu
-
Enrolling Soon
Maine
MaineHealth Pediatric Specialty Care, Portland, ME 04102
Contact
Rebecca Edwards
Phone: +1 (207) 662-6712
Email: rebecca.edwards@mainehealth.org
-
Enrolling Soon
Massachusetts
Boston Children's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling Soon
Massachusetts
Massachusetts General Hospital, Boston, MA 02114
Contact
Margot Hardcastle
Phone: +1 (617) 726-3719
Email: mhardcastle@mgh.harvard.edu
-
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
-
Enrolling Soon
Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
Contact
Debra Driscoll
Phone: +1 (313) 745-2221
Email: ddriscol@med.wayne.edu
-
Enrolling Soon
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55454
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
-
Enrolling Soon
New Jersey
Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ 08903
Contact
Sheila Redding
Phone: +1
Email: sr1238@rwjms.rutgers.edu
-
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
-
Enrolling Soon
Ohio
Toledo Children's Hospital, Toledo, OH 43606
Contact
Kelly Hoot
Phone: +1 (419) 291-4630
Email: kelly.hoot@promedica.org
-
Enrolling Soon
Ohio
Children's Hospital Medical Center of Akron, Akron, OH 44308
Contact
Michelle Parrish
Phone: +1 (330) 543-3089
Email: MParrish@akronchildrens.org
-
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
-
Enrolling Soon
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling Soon
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
Contact
Diane Kitch
Phone: +1 (717) 531-5646
Email: dkitch@pennstatehealth.psu.edu
-
Enrolling Soon
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, PA 15224
Contact
Adrienne DeRicco
Phone: +1 (412) 692-8069
Email: adrienne.dericco2@upmc.edu
-
Enrolling Soon
Texas
University of Texas Southwestern / Children’s Health, Dallas, TX 75207
Contact
Keianna Brown
Phone: +1 (214) 456-5489
Email: Keianna.brown@utsouthwestern.edu
-
Enrolling Soon
Utah
Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, UT 84112
Contact
Kristyn Packer
Phone: +1 (801) 520-5106
Email: kristyn.packer@hsc.utah.edu
-
Enrolling Soon
Vermont
University of Vermont Medical Center, Burlington, VT 05401
Contact
Julie Sweet
Phone: +1 (802) 847-7958
Email: julie.sweet@uvmhealth.org
-
Enrolling Soon
Wisconsin
University of Wisconsin, Madison, WI 53792
Contact
Melanie Nelson
Phone: +1 (608) 265-4617
Email: mnelson@pediatrics.wisc.edu
-
Enrolling Soon
Wisconsin
Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226
Contact
Erin Hubertz
Phone: +1 (414) 955-7019
Email: ehubertz@mcw.edu
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:
30% or greater
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants will have a diagnosis of severe exocrine pancreatic insufficiency and will be on a stable dose of pancreatic enzyme replacement therapy (PERT).
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