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Clinical trial

Analysis of the Effect of Teduglutide Treatment on Intestinal Malabsorption and Paneth Cell Numbers in Patients With Steroid-refractory Gastrointestinal Graft Versus Host Disease (SR-GI-GVHD).

ID
Name
GLP-2 in GVHD
Description
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 arms
Trial start
2017-12-06
Estimated PCD
2019-12-06
Trial end
2019-12-06
Status
Completed
Phase
Early phase I
Treatment
Teduglutide
Treatment of patients with SR-GI-GVHD with teduglutide
Arms:
SR-GI-GVHD
Size
6
Primary endpoint
Paneth cell numbers
2 years
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}
Updated at
2023-11-29

1 organization

1 product

1 indication

Organization
University of Freiburg
Product
Teduglutide
Indication
Graft-Versus-Host Disease