Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01925950
Recruitment Status : Terminated (The study was stopped due to patient enrollment challenges.)
First Posted : August 20, 2013
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Chronic Gastrointestinal Graft vs Host Disease Drug: orBec Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by GVHD in Patients With Chronic GI GVHD
Study Start Date : December 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: orBec
Investigational drug
Drug: orBec
Other Names:
  • oral BDP
  • oral beclomethasone 17,21-dipropionate

Primary Outcome Measures :
  1. GI GVHD symptoms [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent
  • Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
  • Endoscopic findings consistent with GI GVHD
  • 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:

  • >500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
  • GI infection
  • Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • HIV seropositivity
  • Pregnant or nursing female
  • Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
  • Evidence of recurrent or progressing malignant disorder that was the indication for HCT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01925950

United States, New Jersey
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators

Responsible Party: Soligenix Identifier: NCT01925950     History of Changes
Other Study ID Numbers: BDP-GVHD-08
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Soligenix:
beclomethasone dipropionate
bone marrow transplant
hematopoietic cell transplant
stem cell transplant
marrow transplant
beclomethasone 17,21-dipropionate

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents