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Trial · Interventional

CompletedEarly phase 1Registry data

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

NCTNCT04290429 (opens ClinicalTrials.gov in a new tab)Other idGLP-2 in GVHD
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Early phase 1
Enrollment
6 participants (actual)
Sponsor
University of Freiburg · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
6 Dec 2017
Primary completion
6 Dec 2019
Completion
6 Dec 2019
First posted
2 Mar 2020
Last update posted
29 Nov 2023
Conditions
Graft Versus Host Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph Early 1

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

    NCT04290429

    6 Dec 2017 to 6 Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • TeduglutideDrug

Arms1

  • Experimental

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Paneth cell numbers

    Time frame · 2 years

    Registry description

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

Secondary outcomes(2)

  1. Stool frequency

    Time frame · 2 years

    Registry description

    Analysis of patient's stool frequency before and during teduglutide treatment.

  2. Intestinal absorption

    Time frame · 2 years

    Registry description

    Analysis of patient's albumin serum levels before and during teduglutide treatment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

5 results

Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure.

Jeppesen et al. 2012Gastroenterologycited by 348

PMID 22982184DOI 10.1053/j.gastro.2012.09.007PUB-22982184

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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