Page Title
Clinical Trial Finder
Nutritional-GI Enrolling
Study to evaluate ANG003 enzyme therapy in adults with cystic fibrosis who have pancreatic insufficiency. (Anagram ANG003-22-101)
This phase 1 study will evaluate the safety, tolerability, and effectiveness of a single dose of ANG003. One dose of the study drug will be given in place of a participant's usual pancreatic enzymes.
This is an open-label study so no placebo is used, and all participants will receive the study drug. Four dose levels are being evaluated and participants will be randomly assigned to one of these. This study will compare a 24-hour baseline period starting with a test meal and no enzymes, to a 24-hour period starting with a test meal with ANG003. Researchers are testing for changes in health and malabsorption symptoms including abdominal discomfort, bloating, etc. They will also measure the absorption of fat, protein, and carbohydrates.
This study may require blood draws, stool collection, and questionnaires.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 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 must be pancreatic insufficient.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
23 days -
Number of Study Visits:
4
Additional Information
-
Phase: ?more info
Phase One -
Study Sponsor: ?more info
Anagram Therapeutics -
Study Drugs:
Study Sites
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Enrolling
Arkansas
University of Arkansas for Medical Sciences, Little Rock, AR 72205
Contact
Kathleen Hicks
Phone: +1 (501) 686-5527
Email: HicksKathleenT@uams.edu
-
Enrolling
California
Miller Children's and Women's Hospital Long Beach, Long Beach, CA 90806
Contact
Marylee Melendrez
Phone: +1 (562) 933-1851
Email: mmelendrez@memorialcare.org
-
Enrolling
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2517
Email: wilsona@njhealth.org
-
Enrolling Soon
Kentucky
University of Louisville, Louisville, KY 40202
Contact
Melissa Thomas
Phone: +1
Email: mcthom12@louisville.edu
-
Enrolling
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling
Massachusetts
Massachusetts General Hospital, Boston, MA 02114
Contact
Margot Hardcastle
Phone: +1 (617) 726-3719
Email: mhardcastle@mgh.harvard.edu
-
Enrolling
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
-
Enrolling
Michigan
Children's Hospital of Michigan, Detroit, MI 48201
Contact
Aleah Goin
Phone: +1 (313) 745-4737
Email: agoin@dmc.org
-
Enrolling
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
-
Enrolling
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
Contact
Barbara Rodgers
Phone: +1 (603) 650-9718
Email: Barbara.A.Rodgers@hitchcock.org
-
Enrolling
New York
Albany Medical College, Albany, NY 12208
Contact
Anne Denero
Phone: +1 (518) 262-5196
Email: DeneroA@mail.amc.edu
-
Enrolling
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
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling
Ohio
Children's Hospital Medical Center of Akron, Akron, OH 44308
Contact
Michelle Parrish
Phone: +1 (330) 543-3089
Email: MParrish@akronchildrens.org
-
Enrolling
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
University of Cincinnati Medical Center, Cincinnati, OH 45267
Contact
Nicole Hummel
Phone: +1 (513) 558-7036
Email: hummelne@ucmail.uc.edu
-
Enrolling
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
-
Enrolling
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
Utah
Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113
Contact
Jane Vroom
Phone: +1
Email: jane.vroom@hsc.utah.edu
-
Enrolling
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:
18 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 must be pancreatic insufficient.
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