Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:15 PM
Study NCT ID:
NCT01309932
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2011-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600496', 'term': 'peginterferon lambda-1a'}, {'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C571889', 'term': 'asunaprevir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, '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': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2011-03-04', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2011-03-04', 'dispFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs)', 'timeFrame': 'Up to end of treatment ( maximum of 48 weeks) plus 30 days'}, {'measure': 'Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)', 'timeFrame': 'At end of treatment (maximum of 48 weeks)'}, {'measure': 'Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)', 'timeFrame': 'Post-treatment Week 24'}], 'secondaryOutcomes': [{'measure': 'Proportion of HCV genotype 1 subjects with Protocol definition of virologic response (PDR) for Part A and Part B', 'timeFrame': 'Weeks 4, Weeks 12 and post-treatment Weeks 24', 'description': '* Part A PDR is defined as HCV RNA at Week 4 \\< LLOQ and Week 12 undetectable\n* Part B PDR is defined as HCV RNA at Week 2 ≥ 2 log10 decrease (or \\< Lower limit of quantitation (LLOQ) if baseline HCV RNA \\< 2400 IU/mL), Week 4 \\< LLOQ and Week 12 undetectable'}, {'measure': 'Proportion of subjects with either a 2-log or greater decrease in Hepatitis C virus (HCV) Ribonucleic acid (RNA) levels from baseline or undetectable levels of HCV RNA', 'timeFrame': 'Weeks 2, Weeks 4 and Weeks 12'}, {'measure': 'Proportion of subjects with viral breakthrough, defined as confirmed > 1 log10 increase in HCV RNA over nadir or confirmed HCV RNA ≥ Lower limit of quantitation (LLOQ) after confirmed undetectable HCV RNA while on treatment', 'timeFrame': 'Post-treatment Week 48'}, {'measure': 'Proportion of subjects with undetectable HCV RNA at the end of treatment that develop detectable levels of HCV RNA in the post-treatment follow-up period', 'timeFrame': 'Post-treatment Week 48'}, {'measure': 'Serum HCV Ribonucleic acid (RNA) levels over time', 'timeFrame': 'Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)'}, {'measure': 'Proportion of subjects with undetectable HCV RNA over time', 'timeFrame': 'Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)'}, {'measure': 'Time to viral clearance, defined as an absence of detectable HCV RNA', 'timeFrame': 'Day 1, 3, Week 1, 2, 4, 6, 8, 12, 24, 36, end of treatment (Week 48), Post-Treatment at Week 4, 12, 24, 36, 48, and 56'}, {'measure': 'Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Maximum observed serum/plasma concentration (Cmax)', 'timeFrame': 'Cmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)'}, {'measure': 'Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Time to maximum concentration (Tmax)', 'timeFrame': 'Tmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)'}, {'measure': 'Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Minimal observed serum/plasma concentration (Cmin)', 'timeFrame': 'Cmin will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)'}, {'measure': 'Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Area under the serum/plasma concentration-time curve during one dose interval AUC(TAU)', 'timeFrame': 'AUC(TAU) will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)'}, {'measure': 'Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In all subjects, trough concentrations will be assessed (Ctrough)', 'timeFrame': 'Troughs at baseline (week 0), weeks 2, 4, 8, 12, 16, and 24'}, {'measure': 'Proportion of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA', 'timeFrame': 'At end of treatment (maximum of 48 weeks) and follow-up Week 12'}, {'measure': 'Proportion of subjects with 4-week sustained virologic response (SVR4), defined as undetectable HCV RNA', 'timeFrame': 'At end of treatment (maximum of 48 weeks) and follow-up Week 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.', 'detailedDescription': 'Study Classification: Pharmacokinetics/ Pharmacodynamics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\n* Chronic Hepatitis C, Genotype 1\n* HCV RNA \\>100,000 IU/mL at screening;\n* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);\n* Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%\n\nExclusion Criteria:\n\n* Any evidence of liver disease other than HCV;\n* Co-infection with HIV;\n* Diagnosed or suspected hepatocellular carcinoma;\n* Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin'}, 'identificationModule': {'nctId': 'NCT01309932', 'acronym': 'D-LITE', 'briefTitle': 'Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects', 'orgStudyIdInfo': {'id': 'AI452-008'}, 'secondaryIdInfos': [{'id': '2010-022568-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin', 'description': 'Part A', 'interventionNames': ['Biological: Pegylated Interferon Lambda (pegIFNλ)', 'Drug: BMS-790052 (NS5A Inhibitor)', 'Drug: Ribavirin (RBV)', 'Drug: Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)']}, {'type': 'EXPERIMENTAL', 'label': 'A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin', 'description': 'Part A', 'interventionNames': ['Biological: Pegylated Interferon Lambda (pegIFNλ)', 'Drug: Ribavirin (RBV)', 'Drug: BMS-650032 (NS3 Protease Inhibitor)', 'Drug: Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV', 'description': 'Part A', 'interventionNames': ['Drug: Ribavirin (RBV)', 'Biological: Pegylated Interferon Alfa-2a (pegIFNα-2a)', 'Drug: Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)', 'Drug: Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)']}, {'type': 'EXPERIMENTAL', 'label': 'A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)', 'description': 'Part B', 'interventionNames': ['Drug: BMS-790052 (NS5A Inhibitor)', 'Drug: BMS-650032 (NS3 Protease Inhibitor)', 'Biological: Pegylated Interferon Lambda (pegIFNλ)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)', 'description': 'Part B', 'interventionNames': ['Biological: Pegylated Interferon Lambda (pegIFNλ)', 'Drug: Ribavirin (RBV)', 'Drug: BMS-790052 (NS5A Inhibitor)', 'Drug: BMS-650032 (NS3 Protease Inhibitor)']}, {'type': 'EXPERIMENTAL', 'label': 'A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)', 'description': 'Part B', 'interventionNames': ['Drug: BMS-790052 (NS5A Inhibitor)', 'Drug: BMS-650032 (NS3 Protease Inhibitor)', 'Biological: Pegylated Interferon Lambda (pegIFNλ)', 'Drug: Placebo for Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)', 'description': 'Part B', 'interventionNames': ['Biological: Pegylated Interferon Lambda (pegIFNλ)', 'Drug: BMS-790052 (NS5A Inhibitor)', 'Drug: BMS-650032 (NS3 Protease Inhibitor)', 'Drug: Placebo for Ribavirin (RBV)']}], 'interventions': [{'name': 'Pegylated Interferon Lambda (pegIFNλ)', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-914143'], 'description': 'Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response', 'armGroupLabels': ['A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin', 'A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin']}, {'name': 'BMS-790052 (NS5A Inhibitor)', 'type': 'DRUG', 'otherNames': ['BMS-790052'], 'description': 'Tablets, Oral, 60 mg, Once daily, 24 weeks', 'armGroupLabels': ['A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin', 'A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)', 'A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Ribasphere'], 'description': 'Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks', 'armGroupLabels': ['A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin', 'A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin', 'A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV']}, {'name': 'BMS-650032 (NS3 Protease Inhibitor)', 'type': 'DRUG', 'otherNames': ['BMS-650032'], 'description': 'Tablets, Oral, 200 mg, Twice daily, 24 weeks', 'armGroupLabels': ['A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin', 'A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)', 'A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)']}, {'name': 'Pegylated Interferon Alfa-2a (pegIFNα-2a)', 'type': 'BIOLOGICAL', 'otherNames': ['Pegasys®'], 'description': 'Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks', 'armGroupLabels': ['A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV']}, {'name': 'Pegylated Interferon Lambda (pegIFNλ)', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-914143'], 'description': 'Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks', 'armGroupLabels': ['A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)', 'A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Ribasphere'], 'description': 'Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks', 'armGroupLabels': ['A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)']}, {'name': 'Pegylated Interferon Lambda (pegIFNλ)', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-914143'], 'description': 'Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks', 'armGroupLabels': ['A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)', 'A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Ribasphere'], 'description': 'Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks', 'armGroupLabels': ['A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)']}, {'name': 'BMS-790052 (NS5A Inhibitor)', 'type': 'DRUG', 'otherNames': ['BMS-790052'], 'description': 'Tablets, Oral, 60 mg, Once daily, 16 weeks', 'armGroupLabels': ['A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)', 'A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)']}, {'name': 'BMS-650032 (NS3 Protease Inhibitor)', 'type': 'DRUG', 'otherNames': ['BMS-650032'], 'description': 'Tablets, Oral, 200 mg, Twice daily, 16 weeks', 'armGroupLabels': ['A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)', 'A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)']}, {'name': 'Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)', 'type': 'DRUG', 'otherNames': ['Placebo for BMS-650032'], 'description': 'Tablets, Oral, 0 mg, Twice daily, 24 weeks', 'armGroupLabels': ['A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin', 'A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV']}, {'name': 'Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)', 'type': 'DRUG', 'otherNames': ['Placebo for BMS-790052'], 'description': 'Tablets, Oral, 0 mg, Once daily, 24 weeks', 'armGroupLabels': ['A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin', 'A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV']}, {'name': 'Placebo for Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Placebo for Ribasphere'], 'description': 'Tablets, Oral, 0 mg, Twice daily, 24 weeks', 'armGroupLabels': ['A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)']}, {'name': 'Placebo for Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Placebo for Ribasphere'], 'description': 'Tablets, Oral, 0 mg, Twice daily, 16 weeks', 'armGroupLabels': ['A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Group Inc.', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University Of Colorado Denver And Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School Of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '21093', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Bristol-Myers Squibb/David E. Bernstein, Md', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28677', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Center For Liver Disease', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke'S Episcopal Hospital - Baylor College Of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Metropolitan Research', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3168', 'city': 'Clayton Vic', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution'}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '6001', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '7348511', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '060-0033', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '2138587', 'city': 'Kawasaki-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '5458586', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '3500495', 'city': 'Iruma-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '105-0001', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '180-0023', 'city': 'Musashino-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '1010', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Local Institution', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Local Institution', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Fundacion De Investigacion De Diego', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}