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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

NCT00926575

Acute Gastrointestinal Graft vs Host Disease

TERMINATED PHASE3

Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease

NCT00053976

Graft Versus Host Disease

COMPLETED PHASE3

A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

NCT06143891

Chronic Graft Versus Host Disease

ACTIVE_NOT_RECRUITING PHASE3

Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)

NCT01954979

Chronic Graft Versus Host Disease

COMPLETED PHASE1

Phase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD

NCT02176031

Graft Versus Host Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Gastrointestinal Graft vs Host Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

orBec

Investigational drug

Group Type EXPERIMENTAL

orBec

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

orBec

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oral BDP oral beclomethasone 17,21-dipropionate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No