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

Soligenix

Status and phase: Terminated; Phase 3

Conditions: Acute Gastrointestinal Graft vs Host Disease

Treatments: Drug: oral beclomethasone 17,21-dipropionate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00926575

BDP-GVHD-03

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

orBec®

Experimental group

Description:

Investigational drug

Treatment:

Drug: oral beclomethasone 17,21-dipropionate

Placebo

Placebo Comparator group

Description:

Control

Treatment:

Drug: Placebo