A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER 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 GRAFT VS. HOST DISEASE

Phase 1

Active, not recruiting

• Conditions: Patients with acute gastrointestinal Graft Versus Host Disease.; MedDRA version: 12.1Level: LLTClassification code 10064677Term: Graft versus host disease in intestine

• Registration Number: EUCTR2010-022247-37-BE
• Lead Sponsor: Soligenix, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-25
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

1)Patients must be between 10 and 100 days post-allogeneic hematopoietic cell transplantation.
2) Symptoms consistent with GI GVHD with endoscopic evidence of GVHD without another plausible explanation for symptoms.
3) Histologic diagnosis of GVHD within ninety-six (96) hours prior to the first dose of study drug.
4) Absence of GI infection within seven (7) days prior to the first dose of study drug. (For patients with diarrhea, no stool pathogens can be detected; for patients undergoing endoscopic biopsies, no infectious agents can be found).
5) Demonstrated ability to swallow two (2) tablets of the size and configuration of study drug.
6) Anti-candidal prophylaxis with an effective drug prior to the first dose of study drug.
7) If female and of childbearing potential, must be willing to use adequate contraception, as determined by the investigator, for the duration of the study.
8) Ability to read, understand, and sign (or have legal representative sign) appropriate patient informed consent.
9) = (> or =) 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Skin GVHD, other than a slowly evolving rash that involves = (< or =) 50% of the body surface.
2) Definite liver GVHD by liver histology or clinical criteria or evidence of liver dysfunction with a total serum bilirubin >3 mg/dL plus conjugated (direct) serum bilirubin >1.0 mg/dL.
3) >1000 mL/day diarrhea on any one (1) day within three (3) days prior to first dose of study drug.
4) Systemic (oral or IV) corticosteroid use for the purpose of prophylaxis or treatment of GVHD or another inflammatory disease process within thirty (30) days prior to first dose of study drug. Exceptions include: use of corticosteroids as anti-emetics during conditioning therapy, or as a pre-medication for infusion of blood products or, < 2 days of stress coverage. If immediate treatment for presumptive GVHD is clinically indicated, up to two doses of prednisone or equivalent (totaling 1mg/kg/day) may be given while awaiting biopsy results in the 24 hours prior to start of study drug.
5) Persistent vomiting of oral intake that precludes ingestion of study drug tablets.
6) Multi-organ failure, sepsis syndrome, or other condition with high mortality (i.e., life expectancy less than 3 months).
7) Infection of the mouth or esophagus with a fungal organism.
8) Known HIV seropositivity.
9) Pregnancy or lactation.
10)Use of any investigational drug, biologic, or device for treatment of GVHD within previous thirty (30) days.
11) In the Investigator’s opinion, an inability to comply with the study procedures and scheduled study visits.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified