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A drug, apraglutide, to treat acute graft-versus-host disease (GVHD) that has not gotten better with treatment (refractory)

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12 and older

Phase 2

7 Locations

NCT05415410

Clinical Trial Goal


To find out if apraglutide is safe and works well to treat GVHD that is refractory

You may be able to join this trial if you:


  • Are 12 years old or older
  • Have acute GVHD of the lower GI tract
  • Have not taken other types of medication to treat the GVHD other than steroids and ruxolitinib. Your doctor can tell you this
  • Do not have cancer that has come back (relapsed)
  • You agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Apraglutide is a GLP-2 receptor agonist that doctors think will help improve absorption and gut barrier function.

In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
  • Group 1 – Apraglutide at a lower dose
  • Group 2 – Apraglutide at a higher dose 

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group. 
 
You'll get: 
  • Apraglutide – Given as a shot under your skin 1 time each week. The dose you'll get depends on when you start the trial and how safe it has been

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. The clinical trial doctors will check your health for 2 years.

The Food and Drug Administration (FDA) has not yet approved apraglutide. 

Contacts


Eremeeva, +41615513030, clinicaltrials@vectivbio.com

Locations

Stanford Cancer CenterRecruiting

Stanford, California

Colorado Blood Cancer InstituteRecruiting

Denver, Colorado

The Winship Cancer Institute Emory UniversityRecruiting

Atlanta, Georgia

University of IowaRecruiting

Iowa City, Iowa

Massachusetts General HospitalRecruiting

Boston, Massachusetts

The Ohio State UniversityRecruiting

Columbus, Ohio

South Austin Medical CenterRecruiting

Austin, Texas

ClinicalTrials.gov record


NCT05415410

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