Chronic Gastrointestinal Graft vs Host DiseasePhase 2NCT01925950
Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
A Phase 2 study testing orBec in people with Chronic Gastrointestinal Graft vs Host Disease, run by Soligenix at 3 sites in United States.
Trial summary
Use of an oral topically-active glucocorticoid with limited side effects may 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
- Chronic Gastrointestinal Graft vs Host Disease
- What is being tested?
- orBec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2013to May 2015
- Phase
- Phase 2
- 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 >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
Who cannot join
- >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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
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
Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
- Being tested
- orBec, 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.
orBecDrug
Also called oral BDP, oral beclomethasone 17,21-dipropionate
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Control Receives: Drug: Placebo |
| orBec | Experimental | Investigational drug Receives: Drug: orBec |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: The study was stopped due to patient enrollment challenges.
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.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soligenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925950
- Sponsor's protocol ID
- BDP-GVHD-08
- Status last verified
- Oct 2018
- First submitted
- 16 Aug 2013
- Last updated
- 1 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01925950
- Acronym / sponsor ID
- BDP-GVHD-08
- Keywords
- BDP, orBec, GVHD, beclomethasone dipropionate, bone marrow transplant, hematopoietic cell transplant, HCT, stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to patient enrollment challenges.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SoligenixIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Posted 4 Oct 2018
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 may 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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboControl |
| orBec | Experimental | Drug: orBecInvestigational drug |
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 >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
Key exclusion criteria (7 listed)
- >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
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 |
|---|---|---|
| orBecAlso: oral BDP, oral beclomethasone 17,21-dipropionate | Drug | orBec |
| Placebo | Drug | Placebo |
Primary outcome
Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms
Time frame: 16 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing orBec in people with Chronic 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 7 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 1 Nov 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Oct 2018). 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?
Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2018.