Chronic Gastrointestinal Graft vs Host Disease Clinical Trial
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
| NCT number | NCT01925950 |
| Other study ID # | BDP-GVHD-08 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | December 2013 |
| Est. completion date | May 2015 |
| Verified date | October 2018 |
| Source | Soligenix |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | John Theurer Cancer Center | Hackensack | New Jersey |
| United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Soligenix |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms | Patients who achieved a Complete Response (CR) of their GI GVHD Symptoms during the Part 1, 16 week treatment period and who remained a CR at the end of the 16 week treatment period were to be eligible to continue into Part 2 of the study. All others were to discontinue. GI GVHD was assessed using a composite score based on the symptoms of satiety, nausea/vomiting, and anorexia. Each symptom was scored on a scale of 0-3, such that the minimum score = 0 and the maximum score = 9. At entry, all subjects must have a score of = 3. A CR will be defined as a composite score of 0. |
16 weeks |