Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

Acute Gastrointestinal Graft vs Host Disease Clinical Trial

— SUPPORTS  

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal GVHD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00926575
• Other study ID #: BDP-GVHD-03
• Status: Terminated
• Phase: Phase 3
• First received: June 19, 2009
• Last updated: October 10, 2013
• Start date: October 2009
• Est. completion date: May 2012

Study information

• Verified date: August 2013
• Source: Soligenix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesAustralia: Department of Health and Ageing Therapeutic Goods AdministrationSwitzerland: SwissmedicBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 140
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Receipt of allogeneic hematopoietic cell transplant

• Diagnosis of GI graft vs. host disease (GVHD)

• No 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

Exclusion Criteria:

• Significant Skin GVHD

• Liver GVHD

• Persistent vomiting

• HIV positive

• Pregnancy/lactation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gastrointestinal Graft vs Host Disease
• Graft vs Host Disease

Intervention

Drug:
• oral beclomethasone 17,21-dipropionate
Two tablets QID for 50 days
• Placebo
Two tablets QID for 50 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soligenix

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hockenbery DM, Cruickshank S, Rodell TC, Gooley T, Schuening F, Rowley S, David D, Brunvand M, Berryman B, Abhyankar S, Bouvier M, McDonald GB. A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood. 2007 May 15;109(10):4557-63. Epub 2007 Jan 23. — View Citation

McDonald GB, Bouvier M, Hockenbery DM, Stern JM, Gooley T, Farrand A, Murakami C, Levine DS. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998 Jul;115(1):28-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Subjects With GVHD Treatment Failure	The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD	Day 80	No
Secondary	Cumulative Exposure to Prednisone		Day 80	No
Secondary	Survival Status		Day 200	No