NCT04290429

Brief Summary

In this study the investigators evaluate the outcomes of six steroid-refractory GVHD patients with gastrointestinal signs of GVHD that were treated with teduglutide.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

February 26, 2020

Last Update Submit

November 28, 2023

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • Paneth cell numbers

    Quantification of Paneth cell numbers within the intestinal crypts before and during teduglutide treatment.

    2 years

Secondary Outcomes (2)

  • Stool frequency

    2 years

  • Intestinal absorption

    2 years

Study Arms (1)

SR-GI-GVHD

EXPERIMENTAL

Analysis of patient's stool frequency, albumin serum levels and quantification of Paneth cell numbers in GI biopsies before and during teduglutide treatment.

Drug: Teduglutide

Interventions

TeduglutideDRUG

Treatment of patients with SR-GI-GVHD with teduglutide

SR-GI-GVHD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with signs of acute SR-GI-GVHD
  • Age ≥ 18 years
  • Peripheral blood and stool samples available before and during treatment
  • Written informed consent
  • Ability to understand the nature of the study and the study related procedures and to comply with them

You may not qualify if:

  • Age ≤ 18 years
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (6)

  • Zeiser R, Blazar BR. Acute Graft-versus-Host Disease - Biologic Process, Prevention, and Therapy. N Engl J Med. 2017 Nov 30;377(22):2167-2179. doi: 10.1056/NEJMra1609337. No abstract available.

    PMID: 29171820BACKGROUND

  • Drucker DJ, Yusta B. Physiology and pharmacology of the enteroendocrine hormone glucagon-like peptide-2. Annu Rev Physiol. 2014;76:561-83. doi: 10.1146/annurev-physiol-021113-170317. Epub 2013 Oct 25.

    PMID: 24161075BACKGROUND

  • Drucker DJ, Erlich P, Asa SL, Brubaker PL. Induction of intestinal epithelial proliferation by glucagon-like peptide 2. Proc Natl Acad Sci U S A. 1996 Jul 23;93(15):7911-6. doi: 10.1073/pnas.93.15.7911.

    PMID: 8755576BACKGROUND

  • Boushey RP, Yusta B, Drucker DJ. Glucagon-like peptide (GLP)-2 reduces chemotherapy-associated mortality and enhances cell survival in cells expressing a transfected GLP-2 receptor. Cancer Res. 2001 Jan 15;61(2):687-93.

    PMID: 11212269BACKGROUND

  • Jeppesen PB, Hartmann B, Thulesen J, Graff J, Lohmann J, Hansen BS, Tofteng F, Poulsen SS, Madsen JL, Holst JJ, Mortensen PB. Glucagon-like peptide 2 improves nutrient absorption and nutritional status in short-bowel patients with no colon. Gastroenterology. 2001 Mar;120(4):806-15. doi: 10.1053/gast.2001.22555.

    PMID: 11231933BACKGROUND

  • Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012 Dec;143(6):1473-1481.e3. doi: 10.1053/j.gastro.2012.09.007. Epub 2012 Sep 11.

    PMID: 22982184BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Robert Zeiser, Prof. Dr.

    Medical Center University of Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Division of Tumor Immunology

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 2, 2020

Study Start

December 6, 2017

Primary Completion

December 6, 2019

Study Completion

December 6, 2019

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)