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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Soligenix
Sponsor:
Information provided by (Responsible Party):
Soligenix
ClinicalTrials.gov Identifier:
NCT01925950
First received: August 16, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Chronic Gastrointestinal Graft vs Host Disease
Drug: orBec
Drug: Placebo
Phase 2

Study Type: 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
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

Resource links provided by NLM:


Further study details as provided by Soligenix:

Primary Outcome Measures:
  • GI GVHD symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Control
Drug: Placebo
Experimental: orBec
Investigational drug
Drug: orBec
Other Names:
  • oral BDP
  • oral beclomethasone 17,21-dipropionate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925950

Contacts
Contact: Adam Rumage 609-538-8200

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

No publications provided

Responsible Party: Soligenix
ClinicalTrials.gov Identifier: NCT01925950     History of Changes
Other Study ID Numbers: BDP-GVHD-08
Study First Received: August 16, 2013
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Soligenix:
BDP
orBec
GVHD
beclomethasone dipropionate
bone marrow transplant
hematopoietic cell transplant
HCT
stem cell transplant
marrow transplant
SCT
beclomethasone 17,21-dipropionate

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

ClinicalTrials.gov processed this record on October 21, 2014