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Clinical Trial Results:
Double-blind, randomised, placebo-controlled multicentre phase III clinical study followed by open-label phase on the efficacy and tolerability of budesonide 3 mg effervescent tablet in patients with resistant oral chronic GvHD

Summary
EudraCT number	2008-004562-10
Trial protocol	DE AT FR SE IT CZ
Global end of trial date	20 Jul 2015

Results information
Results version number	v1(current)
This version publication date	26 Aug 2018
First version publication date	26 Aug 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

BUM-5/GVH

ISRCTN number

US NCT number

NCT00887263

WHO universal trial number (UTN)

Sponsor organisation name

Dr. Falk Pharma GmbH

Sponsor organisation address

Leinenweberstr. 5, Freiburg, Germany, 79108

Public contact

Department of Clinical Research, Dr. Falk Pharma GmbH, 49 761 1514-0, zentrale@drfalkpharma.de

Scientific contact

Department of Clinical Research, Dr. Falk Pharma GmbH, 49 761 1514-0, zentrale@drfalkpharma.de

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

11 Jul 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

20 Jul 2015

Global end of trial reached?

Yes

Global end of trial date

20 Jul 2015

Was the trial ended prematurely?

Main objective of the trial

• To compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) vs. placebo for the treatment of patients with resistant oral chronic graft versus host disease (cGvHD) • To study safety and tolerability in the form of adverse events and laboratory parameters

Protection of trial subjects

Close supervision of subjects by implementing interim visits every 14 days (during 12 weeks double-blind phase) and then every 2 to 12 weeks (during 40 weeks open-label phase) to guarantee their safety and wellbeing. Prior to recruitment of patients, all relevant documents of the clinical study were submitted and proved by the Independent Ethics Committees (IECs) responsible for the participating investigators. Written consent documents embodied the elements of informed consent as described in the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice (GCP) and were in accordance with all applicable laws and regulations. The informed consent form and patient information sheet described the planned and permitted uses, transfers and disclosures of the patient's personal data and personal health information for purposes of conducting the study. The informed consent form and the patient information sheet further explained the nature of the study, its objectives and potential risks and benefits as well as the date informed consent was given. Before being enrolled in the clinical trial, every patient was informed that participation in this trial was voluntary and that he/she could withdraw from the study at any time without giving a reason and without having to fear any loss in his/her medical care. The patient’s consent was obtained in writing before the start of the study. By signing the informed consent, the patient declared that he/she was participating voluntarily and intended to follow the study protocol instructions and the instructions of the investigator and to answer the questions asked during the course of the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

30 Mar 2009

Long term follow-up planned

Yes

Long term follow-up rationale

Ethical reason, Regulatory reason

Long term follow-up duration

5 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country