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Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients

NCT ID: NCT04290429

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2019-12-06

Brief Summary

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

Detailed Description

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Preliminary studies have showed that Glucagon-like peptide 2 (GLP-2) has regenerative and protective effects on the gastrointestinal tract after bowel injury. It induces positive effects in the GI tract like nutrient uptake, mucosal growth, protection from inflammation, etc. One of the target organs from GVHD is the GI tract, and since patients suffering from GI-GVHD experience intestinal disorders like loss of mucosal epithelial integrity, diarrhea accompanied by strong abdominal pain that can lead to food inanition, the investigators therefore aimed to examine the outcome of patients suffering from SR-GI-GVHD that are treated with the GLP-2 analogue, Teduglutide. The investigators will determine the outcome of each patient by monitoring the gastrointestinal signs like diarrhea frequency, intestinal absorption measured by serum-albumin concentrations and GI histology, specifically the number of Paneth cells before and during teduglutide treatment.

Conditions

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Graft Versus Host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SR-GI-GVHD

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

Group Type EXPERIMENTAL

Teduglutide

Intervention Type DRUG

Treatment of patients with SR-GI-GVHD with teduglutide

Interventions

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Teduglutide

Treatment of patients with SR-GI-GVHD with teduglutide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Age ≤ 18 years
* Lack of informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Freiburg

OTHER

Sponsor Role lead

Responsible Party

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Robert Zeiser

Director of the Division of Tumor Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Zeiser, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical Center University of Freiburg

Locations

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Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 29171820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24161075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8755576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11212269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11231933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22982184 (View on PubMed)

Other Identifiers

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GLP-2 in GVHD

Identifier Type: -

Identifier Source: org_study_id