Patients with acute gastrointestinal Graft Versus Host Disease. MedDRA version: 12.1 Level: LLT Classification code 10064677 Term: Graft versus host disease in intestine
Conditions
Interventions
beclomethasone dipropionate (USAN, BAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the
Product Name: oral beclomethasone 17,21-dipropionate
Product Code: BDP
Pharmaceutical Form: Tablet
INN or Proposed INN: Beclometasone dipropionate
CAS Number: 5534-09-8
Current Sponsor code: 2106DM0 f
beclomethasone dipropionate (USAN, BAN)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of admi
Sponsors
Soligenix, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1) Skin GVHD, other than a slowly evolving rash that involves = (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this confirmatory, multi-center study is to compare the efficacy, defined as the proportion of subjects who are GVHD treatment successes vs. failures, of an oral BDP regimen consisting of an induction course of prednisone [1 mg/kg/day for ten (10) days] plus 8 mg/day BDP for fifty (50) days, with the efficacy of an induction course of prednisone [1 mg/kg/day for ten (10) days] plus placebo tablets for fifty (50) days, in subjects with acute gastrointestinal (GI) GVHD.;Secondary Objective: a. Cumulative prednisone exposure (in mg/kg/day) received while under observation during the 80-day study period. b. The occurrence of GVHD treatment failure during the 50-day study drug treatment period. c. Survival status at Study Day 200 post-randomization. d. The presence or absence of active acute GI GVHD at Study Day 110.;Primary end point(s): The occurrence (yes/no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD. | — |
Countries
Belgium, Germany
Outcome results
None listed