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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Acute Gastrointestinal Graft vs Host Disease

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The proportion of subjects with GVHD treatment failure

Outcome Time Frame:

Day 80

Safety Issue:

No

Principal Investigator

Keith Sullivan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

BDP-GVHD-03

NCT ID:

NCT00926575

Start Date:

October 2009

Completion Date:

May 2012

Related Keywords:

  • Acute Gastrointestinal Graft vs Host Disease
  • BDP
  • orBec
  • GVHD
  • beclomethasone dipropionate
  • bone marrow transplant
  • hematopoietic cell transplant
  • HCT
  • stem cell transplant
  • marrow transplant
  • SCT
  • beclomethasone 17,21-dipropionate
  • Graft vs Host Disease

Name

Location
Albany, New York  12208
Seattle, Washington  98195
Charlotte, North Carolina