Budesonide for Prevention of Acute Gastrointestinal GVHD... | NCT00180089

Studies
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation

NCT00180089

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Mar 30, 2010Estimated

Enrollment

242Estimated

Phase

Phase 3

Conditions

Leukemia
Graft-Versus-Host Disease

Interventions

Budesonide

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Mar 2009Actual

Completion Date

Jan 2010

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2010

Last Update Posted Date

Mar 30, 2010Estimated

Name	Class
Dr. Falk Pharma GmbH	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine whether orale budesonide is effective in the prevention of acute gastrointestinal graft-versus-host disease (GVHD) following allogenic stem cell transplantation.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

242Estimated

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of acute gastrointestinal (GI) GVHD in the active group versus placebo group

Secondary Outcomes

Measure	Description	Time Frame
safety
grade of acute GI GVHD
incidence of chronic GI GVHD

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

planned allogenic stem cell or bone marrow transplantation
HLA identity (max. 1 mismatch)
standard GVHD prophylaxis with cyclosporin A or tacrolimus combined with MTX, +/- ATG or Campath1H
written informed consent

Exclusion Criteria:

history of allogenic transplantation
in vitro T-cell depleted transplant
pretreatment with budesonide within the previous 4 weeks
known intolerance to budesonide
gastrointestinal infections
portal hypertension
concomitant infectious diseases
liver cirrhosis, impaired liver function
severe mental disorder
lack of compliance
drug or alcohol abuse
pregnancy, lactation
childbearing potential without effective contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Miehlke, Prof.	Medical Department I, Technical University Hospital, Dresden, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Department I, Technical University Hospital		Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25425214	Derived	Schmelz R, Bornhauser M, Schetelig J, Kiani A, Platzbecker U, Schwanebeck U, Grahlert X, Uharek L, Aust D, Baretton G, Schwerdtfeger R, Hampe J, Greinwald R, Mueller R, Ehninger G, Miehlke S. Randomised, double-blind, placebo-controlled trial of oral budesonide for prophylaxis of acute intestinal graft-versus-host disease after allogeneic stem cell transplantation (PROGAST). BMC Gastroenterol. 2014 Nov 26;14:197. doi: 10.1186/s12876-014-0197-7.

ID	Term
D007938	Leukemia
D006086	Graft vs Host Disease

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473