Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 11:26 AM
Study NCT ID:
NCT01925950
Status:
TERMINATED
Last Update Posted:
2018-11-01
First Post:
2013-08-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C048053', 'term': 'alpha-ketoisovalerate dehydrogenase phosphatase'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '609-538-8200', 'title': 'Dr. Richard Straube', 'organization': 'Soligenix, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '48-week study period', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.\n\nPart 1: 2 mg of placebo 4 times per day for up to 16 weeks.\n\nPart 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:\n\nWeeks 17-24: 2 mg placebo 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg placebo 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg placebo daily, up to 16 weeks.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'orBec', 'description': 'orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.\n\nPart 1: 2 mg of orBec 4 times per day for up to 16 weeks.\n\nPart 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:\n\nWeeks 17-24: 2 mg orBec 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg orBec 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg orBec daily, up to 16 weeks.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'biliary strictures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'fungal pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'pulmonary emboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'intractable pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.\n\n2 mg of placebo 4 times per day for up to 16 weeks.'}, {'id': 'OG001', 'title': 'orBec', 'description': 'orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.\n\n2 mg of orBec 4 times per day for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': '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.\n\nGI 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching placebo was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.\n\nPart 1: 2 mg of placebo 4 times per day for up to 16 weeks.\n\nPart 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:\n\nWeeks 17-24: 2 mg placebo 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg placebo 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg placebo daily, up to 16 weeks.'}, {'id': 'FG001', 'title': 'orBec', 'description': 'orBec, oral beclomethasone dipropionate, was formulated as 1 mg immediate release (IR) and 1 mg delayed release (DR) tablets, which comprised 1 dose of study drug.\n\nPart 1: 2 mg of orBec 4 times per day for up to 16 weeks.\n\nPart 2: Patients who achieved a Complete Response (CR) on Part 1 were to taper study drug according to the following schedule:\n\nWeeks 17-24: 2 mg orBec 3 times per day, up to 8 weeks; Weeks 25-32: 2 mg orBec 2 times per day, up to 8 weeks; Weeks 33-48: 2 mg orBec daily, up to 16 weeks.'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'comment': 'The 1 orBec subject completed Part 1 but did not meet the criteria of a CR to continue to Part 2', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Control\n\nPlacebo'}, {'id': 'BG001', 'title': 'orBec', 'description': 'Investigational drug\n\norBec'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'The study was stopped due to patient enrollment challenges.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-03', 'studyFirstSubmitDate': '2013-08-16', 'resultsFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2013-08-16', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-07', 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms', 'timeFrame': '16 weeks', 'description': '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.\n\nGI 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BDP', 'orBec', 'GVHD', 'beclomethasone dipropionate', 'bone marrow transplant', 'hematopoietic cell transplant', 'HCT', 'stem cell transplant', 'marrow transplant', 'SCT', 'beclomethasone 17,21-dipropionate'], 'conditions': ['Chronic Gastrointestinal Graft vs Host Disease']}, 'descriptionModule': {'briefSummary': 'Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Receipt of allogeneic hematopoietic cell transplant \\>100 days prior to consent\n* 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)\n* Endoscopic findings consistent with GI GVHD\n* Must be able to swallow tablets\n* Must be able to read and understand informed consent\n* Adequate birth control methods for the duration of the study\n\nExclusion Criteria:\n\n* \\>500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug\n* GI infection\n* Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.\n* HIV seropositivity\n* Pregnant or nursing female\n* Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug\n* Evidence of recurrent or progressing malignant disorder that was the indication for HCT"}, 'identificationModule': {'nctId': 'NCT01925950', 'briefTitle': 'Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Soligenix'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BDP-GVHD-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Control', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'orBec', 'description': 'Investigational drug', 'interventionNames': ['Drug: orBec']}], 'interventions': [{'name': 'orBec', 'type': 'DRUG', 'otherNames': ['oral BDP', 'oral beclomethasone 17,21-dipropionate'], 'armGroupLabels': ['orBec']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'John Theurer Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soligenix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}