Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000593033
Ethics application status
Approved
Date submitted
14/07/2010
Date registered
22/07/2010
Date last updated
22/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of orBec (Registered Trademark (R)) With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec(R) (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal Graft Versus Host Disease (GVHD)
Secondary ID [1] 252225 0
Study NCT00926575 ClinicalTrials.gov
Universal Trial Number (UTN)
Trial acronym
SUPPORTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Graft Versus Host Disease 257747 0
Condition category
Condition code
Oral and Gastrointestinal 257922 257922 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 257923 257923 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
oral beclomethasone 17,21-dipropionate
Two pills (1 milligram) four times a day (8 milligrams) for 50 days.
Study drug administered in conjunction with standard of care prednisone therapy.
Intervention code [1] 256812 0
Treatment: Drugs
Comparator / control treatment
Placebo
Two pills (1 milligram lactose monohydrate) four times a day (8 millligrams) for 50 days.
Placebo administered in conjunction with standard of care prednisone therapy.
Control group
Placebo

Outcomes
Primary outcome [1] 258785 0
The proportion of subjects with GVHD treatment failure defined as the increased use of prednisone or equivalent intravenous (IV) corticosteroids at doses higher than specified in the protocol or use of any other additional glucocorticoid or the addition of other immunosuppresant medications, in response to uncontrolled signs or symptoms of GVHD.
Timepoint [1] 258785 0
Day 80
Secondary outcome [1] 264846 0
Cumulative exposure to prednisone assessed by medication records
Timepoint [1] 264846 0
Day 80
Secondary outcome [2] 264847 0
Survival status via telephone follow-up calls
Timepoint [2] 264847 0
Day 200

Eligibility
Key inclusion criteria
*Receipt of allogeneic hematopoietic cell transplant
*Diagnosis of gastrointestinal graft versus host disease (GVHD)
*No gastrointestinal (GI) infection
*Must be able to swallow tablets
*Must be able to read and understand informed consent
*Adequate birth control methods for the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Significant Skin Graft Versus Host Disease
*Liver Graft Versus Host Disease
*Persistent vomiting
*Human Immunodeficiency Virus (HIV) positive
*Pregnancy/lactation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by telphone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors such as centre, age gender or previous treatment are used for the stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
166
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2767 0
United States of America
State/province [1] 2767 0

Funding & Sponsors
Funding source category [1] 257288 0
Commercial sector/Industry
Name [1] 257288 0
Soligenix, Inc.
Country [1] 257288 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Soligenix, Inc.
Address
29 Emmons Drive
Suite C-10
Princeton, NJ 08540
Country
United States of America
Secondary sponsor category [1] 256533 0
None
Name [1] 256533 0
Address [1] 256533 0
Country [1] 256533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259314 0
Fred Hutchinson Cancer Research Center Institutional Review Board
Ethics committee address [1] 259314 0
1100 Fairview Avenue North
J6-110
Seattle, Washington 98109-1024
Ethics committee country [1] 259314 0
United States of America
Date submitted for ethics approval [1] 259314 0
Approval date [1] 259314 0
12/08/2009
Ethics approval number [1] 259314 0

Summary
Brief summary
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31398 0
Address 31398 0
Country 31398 0
Phone 31398 0
Fax 31398 0
Email 31398 0
Contact person for public queries
Name 14645 0
Brian L. Hamilton, MD, PhD
Address 14645 0
29 Emmons Drive
Suite C-10
Princeton, NJ 08540
Country 14645 0
United States of America
Phone 14645 0
+1 609-538-8200
Fax 14645 0
Email 14645 0
bhamilton@soligenix.com
Contact person for scientific queries
Name 5573 0
Brian L. Hamilton, MD, PhD
Address 5573 0
29 Emmons Drive
Suite C-10
Princeton, NJ 08540
Country 5573 0
United States of America
Phone 5573 0
+1 609-538-8200
Fax 5573 0
Email 5573 0
bhamilton@soligenix.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.