Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-08 @ 9:49 PM
Study NCT ID:
NCT01980095
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2013-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ira@redhillbio.com', 'phone': '1-917-817-7517', 'title': 'Dr. Ira Kalfus', 'organization': 'RedHill Biopharma'}, 'certainAgreement': {'otherDetails': 'The PI agree that the Sponsor shall have the right to the first publication of the results of the Study. Following the first publication, the PI may publish data or results from the Study; subject to Sponsor for review and approval in writing at least sixty (60) days prior to the date of the publication. Sponsor may require changes and may extend the embargo to protect its intellectual property or other proprietary interests and to allow for the taking actions for this purpose.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year and 10 months', 'eventGroups': [{'id': 'EG000', 'title': 'RHB-105', 'description': "RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.", 'otherNumAtRisk': 77, 'otherNumAffected': 38, 'seriousNumAtRisk': 77, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Identical capsules that look like the RHB-105 product but contain no active ingredient.', 'otherNumAtRisk': 41, 'otherNumAffected': 17, 'seriousNumAtRisk': 41, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Anemia of Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Perirectal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RHB-105', 'description': "RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.\n\nTotal daily dose of:\n\n* Rifabutin 150 mg\n* Amoxicillin 3000 mg\n* Omeprazole 120 mg"}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsules that look like the RHB-105 product but contain no active ingredient.\n\nPlacebo: Subjects will take 4 placebo capsules every 8 hours with food for 14 days.'}], 'classes': [{'categories': [{'title': 'H. pylori eradication success', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'H. pylori eradication failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'One-sample Z-test, RHB-105 subjects only', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28-56 days after completion of treatment', 'description': 'Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT Population included all subjects who received at least 1 dose of randomized study treatment and underwent a 13C UBT test at Visit 4. This population consisted in 66 subjects in the RHB-105 group and 37 subjects in the placebo group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'H. Pylori Eradication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Subjects', 'description': 'These patients failed h.pylori eradication on study drug (placebo) and were subsequently treated with standard of care therapy as per the investigator'}, {'id': 'OG001', 'title': 'Active Drug Eradication Failure Subjects', 'description': 'These patients failed h.pylori eradication on study drug (active) and were subsequently treated with standard of care therapy as per the investigator.'}], 'classes': [{'categories': [{'title': 'H. pylori eradication success', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'H. pylori eradication failure', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28-56 days after completion of SOC treatment', 'description': 'The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eradication Failure Subjects at Visit 4 were treated with standard of care therapy by the investigator and performed a 13C Urea Breath Test at Visit 8 to confirm H. pylori eradication. This population included 27 subjects in the placebo group and 4 subjects in the active drug eradication failure subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RHB-105', 'description': "RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.\n\nTotal daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg"}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Capsules that look like the RHB-105 product but contain no active ingredient.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Protocol planned for 90 patients, protocol amendment increase up to 120 patients.', 'groupId': 'FG000', 'numSubjects': '78'}, {'comment': 'Protocol planned for 90 patients, protocol amendment increase up to 120 patients.', 'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Treated', 'achievements': [{'comment': 'Of 78 patients randomized, 1 patient erroneously randomized and not treated', 'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Poor compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Safety issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study drug discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized by mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RHB-105', 'description': "RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.\n\nTotal daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg."}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Capsules that look like the RHB-105 product but contain no active ingredient.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'spread': '10.56', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '9.52', 'groupId': 'BG001'}, {'value': '46', 'spread': '10.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-15', 'studyFirstSubmitDate': '2013-11-04', 'resultsFirstSubmitDate': '2016-11-13', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-13', 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'H. Pylori Eradication', 'timeFrame': '28-56 days after completion of SOC treatment', 'description': 'The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment'}], 'primaryOutcomes': [{'measure': 'The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing', 'timeFrame': '28-56 days after completion of treatment', 'description': 'Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'H. pylori', 'Dyspepsia'], 'conditions': ['Dyspepsia', 'Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '34862940', 'type': 'DERIVED', 'citation': 'Howden CW, Sheldon KL, Almenoff JS, Chey WD. Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data. Dig Dis Sci. 2022 Sep;67(9):4382-4386. doi: 10.1007/s10620-021-07323-5. Epub 2021 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients.', 'detailedDescription': 'This is a, randomized, double-blind, placebo-controlled study of RHB-105 in adult subjects complaining of epigastric discomfort that have been screened and found to be positive for H. pylori infection via 13C Urea Breath Test (UBT) and either fecal antigen test or CLO test.\n\nEligible subjects will be randomized in a ratio of 1:2 between placebo arm (n=30) and the active arm (RHB-105) (n=60). Subjects will receive study drug for 14 consecutive days. Eradication of H. pylori infection will be determined based on 13C UBT conducted between 28 to 56 days after completion of study drug therapy.\n\nSubjects will be unblinded upon 13C UBT analysis. This will provide timely active therapy to all subjects enrolled in this study. Subjects in the placebo arm will be entitled to receive standard-of-care as prescribed by the treating physician following un-blinding.\n\nEradication failures (13C UBT-positive) in the active study drug arm will undergo upper endoscopy with sampling for culture and sensitivity testing (to rifabutin, amoxicillin, clarithromycin, and metronidazole). Culture and sensitivity directed therapy as prescribed by the treating physician will be offered to these subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be ≥18 years of age and ≤ 65 years\n2. Have symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals)\n3. Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test\n4. Be informed of the nature of the study and provide written informed consent before any study specific procedures are performed (or have a legally authorized representative sign consent)\n\nExclusion Criteria:\n\n1. Have alarm symptoms/signs (including unexplained anemia \\[iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss)\n2. Have taken antibiotics in the 4 weeks prior to screening\n3. Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening\n4. Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer\n5. Have a history of gastric outlet obstruction\n6. Have a history of hypersecretory state such as Zollinger-Ellison Syndrome\n7. Have a history of gastric cancer\n8. Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers'}, 'identificationModule': {'nctId': 'NCT01980095', 'acronym': 'ERADICATE Hp', 'briefTitle': 'ERADICATE Hp - Treating Helicobacter Pylori With RHB-105', 'organization': {'class': 'INDUSTRY', 'fullName': 'RedHill Biopharma Limited'}, 'officialTitle': 'A Randomized Placebo-Controlled Phase 3 Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection in Non-investigated Dyspepsia Patients', 'orgStudyIdInfo': {'id': 'RHB-105-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RHB-105', 'description': "RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.", 'interventionNames': ['Drug: RHB-105']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsules that look like the RHB-105 product but contain no active ingredient.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RHB-105', 'type': 'DRUG', 'description': 'The intended dose is RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of:\n\n* Rifabutin 150 mg\n* Amoxicillin 3000 mg\n* Omeprazole 120 mg\n\nSubjects will take study drug every 8 hours with food for 14 consecutive days.', 'armGroupLabels': ['RHB-105']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will take 4 placebo capsules every 8 hours with food for 14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91710', 'city': 'Chino', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute', 'geoPoint': {'lat': 34.01223, 'lon': -117.68894}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Research, Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Columbus Regional Research Institute', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MedPharmics', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '41401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigative Clinical Research', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'MGG Group Co. Chevy Chase Clinical Research', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit Clinical Research Center', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Office of Dr. Stephen Miller, MD', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Peters Medical Research', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'overallOfficials': [{'name': 'David Y Graham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RedHill Biopharma Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}