Acute Gastrointestinal Graft vs Host DiseasePhase 3SUPPORTSNCT00926575

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

A Phase 3 study testing oral beclomethasone 17,21-dipropionate in people with Acute Gastrointestinal Graft vs Host Disease, run by Soligenix at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Gastrointestinal Graft vs Host Disease
What is being tested?: oral beclomethasone 17,21-dipropionate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 3 sitesUnited States
Study dates: Oct 2009to May 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Receipt of allogeneic hematopoietic cell transplant
Diagnosis of GI graft vs. host disease (GVHD)
No GI infection
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

Who cannot join

Significant Skin GVHD
Liver GVHD
Persistent vomiting
HIV positive
Pregnancy/lactation

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Buffalo, New York
Study site
Durham, North Carolina
Study site
Seattle, Washington

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter 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 GVHD

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

Conditions: Acute Gastrointestinal Graft vs Host Disease
Being tested: oral beclomethasone 17,21-dipropionate, Placebo
Keywords: BDP, orBec, GVHD, beclomethasone dipropionate, bone marrow transplant, hematopoietic cell transplant, HCT, stem cell transplant, marrow transplant, SCT, beclomethasone 17,21-dipropionate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral beclomethasone 17,21-dipropionateDrug
Also called orBec, BDP
Two tablets QID for 50 days
PlaceboDrug
Two tablets QID for 50 days

Study groups in NCT00926575
Study group	Role	What they receive
orBec®	Experimental	Investigational drug Receives: Drug: oral beclomethasone 17,21-dipropionate
Placebo	Placebo comparator	Control Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Proportion of Subjects With GVHD Treatment Failure
The primary endpoint is 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
Measured: Day 80

Secondary outcomes (2)

Cumulative Exposure to Prednisone
Measured: Day 80
Survival Status
Measured: Day 200

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009May 2012

First posted23 Jun 2009 (estimated)
Study startOct 2009
Primary completionDec 2011
Study completionMay 2012

Why it stopped: An independent Data Safety Monitoring Board recommended the study be stopped due to futility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Gastrointestinal Graft vs Host DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00926575
Sponsor's protocol ID: BDP-GVHD-03
Acronym: SUPPORTS
Status last verified: Aug 2013
First submitted: 19 Jun 2009
Last updated: 6 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

McDonald GB, Bouvier M, Hockenbery DM, Stern JM, Gooley T, Farrand A, Murakami C, Levine DS. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998 Jul;115(1):28-35. doi: 10.1016/s0016-5085(98)70361-0.
PubMed 9649455
Hockenbery DM, Cruickshank S, Rodell TC, Gooley T, Schuening F, Rowley S, David D, Brunvand M, Berryman B, Abhyankar S, Bouvier M, McDonald GB. A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood. 2007 May 15;109(10):4557-63. doi: 10.1182/blood-2006-05-021139. Epub 2007 Jan 23.
PubMed 17244684

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
RecruitingPhase 3
Fecal Microbiota Transplantation in aGvHD After ASCT
Graft Versus Host Disease in GI Tract
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Enrolling by invitationEarly Phase 1
Prospective Randomized Controlled Study: Amimaitosai Injection Combined With Corticosteroids for Gastrointestinal aGVHD
Acute Gastrointestinal Graft-versus-host Disease
RecruitingPhase 2
Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD
Graft vs Host Disease

All Acute Gastrointestinal Graft vs Host Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter 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 GVHD
ClinicalTrials.gov ID: NCT00926575
Acronym / sponsor ID: SUPPORTS / BDP-GVHD-03
Conditions: Acute Gastrointestinal Graft vs Host Disease
Keywords: BDP, orBec, GVHD, beclomethasone dipropionate, bone marrow transplant, hematopoietic cell transplant, HCT, stem cell transplant
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: An independent Data Safety Monitoring Board recommended the study be stopped due to futility
Enrolment: 140 participants (actual)
Lead sponsor: SoligenixIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2011 (actual)
Study completion: May 2012 (actual)
First posted: 23 Jun 2009 (estimated)
Results: Posted 6 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
orBec®	Experimental	Drug: oral beclomethasone 17,21-dipropionateInvestigational drug
Placebo	Placebo comparator	Drug: PlaceboControl

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Receipt of allogeneic hematopoietic cell transplant
Diagnosis of GI graft vs. host disease (GVHD)
No GI infection
Must be able to swallow tablets
Must be able to read and understand informed consent

Key exclusion criteria (5 listed)

Significant Skin GVHD
Liver GVHD
Persistent vomiting
HIV positive
Pregnancy/lactation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
oral beclomethasone 17,21-dipropionateAlso: orBec, BDPTwo tablets QID for 50 days	Drug	orBec®
PlaceboTwo tablets QID for 50 days	Drug	Placebo

Primary outcome

The Proportion of Subjects With GVHD Treatment Failure
Time frame: Day 80
The primary endpoint is 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

2 secondary outcomes

Cumulative Exposure to Prednisone
Time frame: Day 80
Survival Status
Time frame: Day 200

Results and safety

Results posted to the registry on 6 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	70	54
Placebo	70	53

Primary outcome: The Proportion of Subjects With GVHD Treatment Failure

Time frame: Day 80

Population analysed: Data was not analyzed as the study was terminated due to futility

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 80. Other adverse events reported at 1.43% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	32 of 70 (45.7%)	70 of 70 (100%)	Not reported
Placebo	28 of 70 (40%)	70 of 70 (100%)	Not reported

Limitations and caveats (from the sponsor): DSMB terminated study for futility; no safety concerns during analysis of patient population. Overall, 1 SAE considered possibly related to study drug, all others were not related to study drug.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9649455McDonald GB, Bouvier M, Hockenbery DM, Stern JM, Gooley T, Farrand A, Murakami C, Levine DS. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998 Jul;115(1):28-35. doi: 10.1016/s0016-5085(98)70361-0.
Background: PubMed 17244684Hockenbery DM, Cruickshank S, Rodell TC, Gooley T, Schuening F, Rowley S, David D, Brunvand M, Berryman B, Abhyankar S, Bouvier M, McDonald GB. A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease. Blood. 2007 May 15;109(10):4557-63. doi: 10.1182/blood-2006-05-021139. Epub 2007 Jan 23.

Related trials for Acute Gastrointestinal Graft vs Host Disease

RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
RecruitingPhase 3
Fecal Microbiota Transplantation in aGvHD After ASCT
Graft Versus Host Disease in GI Tract
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Enrolling by invitationEarly Phase 1
Prospective Randomized Controlled Study: Amimaitosai Injection Combined With Corticosteroids for Gastrointestinal aGVHD
Acute Gastrointestinal Graft-versus-host Disease
RecruitingPhase 2
Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD
Graft vs Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Keith Sullivan, MD principal investigator

Duke University

David Hockenbery, MD principal investigator

Fred Hutchinson Cancer Center

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing oral beclomethasone 17,21-dipropionate in people with Acute Gastrointestinal Graft vs Host Disease, run by Soligenix at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Proportion of Subjects With GVHD Treatment Failure (time frame: Day 80). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00926575, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2013.