Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-22 @ 12:27 AM
Study NCT ID:
NCT03042520
Status:
UNKNOWN
Last Update Posted:
2021-10-12
First Post:
2016-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D003449', 'term': 'Cryoglobulinemia'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-10', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment', 'timeFrame': '6 years', 'description': 'Number of participants with liver-related morbidity during 5-year follow-up period after sofosbuvir-based treatment, including liver fibrosis progression and decompensation'}, {'measure': 'Number of participants with liver-related mortality development during 5-year follow-up period after sofosbuvir-based treatment', 'timeFrame': '6 years', 'description': 'Number of participants with liver-related mortality assessed by death due to HCC and/or liver decompensation'}, {'measure': 'Number of participants with hepatocellular carcinoma (HCC) development during 5-year follow-up period after sofosbuvir-based treatment', 'timeFrame': '6 years', 'description': 'Number of participants with HCC assessed by histocytology or positive dynamic image plus alpha fetoprotein (AFP) \\> 400 ng/ml'}], 'secondaryOutcomes': [{'measure': 'Life quality', 'timeFrame': '6 years', 'description': 'The change of short form(SF)-36 from baseline'}, {'measure': 'Cryoglobulinemia', 'timeFrame': '6 years', 'description': 'Change of proportion of participants with cryoglobulinemia from baseline cryoglobulinemia from baseline)'}, {'measure': 'Diabetes mellitus (DM)', 'timeFrame': '6 years', 'description': 'Number of participants without DM develop DM assessed by Ac sugar \\> 126 g/ml'}, {'measure': 'Insulin resistance', 'timeFrame': '6 years', 'description': 'Change of homeostatic model assessment (HOMA-IR), assessed by Glucose x insulin/22.5 from baseline'}, {'measure': 'Lipid profiles', 'timeFrame': '6 years', 'description': 'Change of the serum profile of lipids including triglyceride(TG), cholesterol(Chol), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) from baseline'}, {'measure': 'Renal disease', 'timeFrame': '6 years', 'description': 'the change of the estimated glomerular filtration rate (eGFR) from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Fibroses', 'HepatoCellular Carcinoma', 'Cryoglobulinemia', 'Metabolic Disease', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '40205145', 'type': 'DERIVED', 'citation': 'Huang CF, Heo J, Chien RN, Baek YH, Kao JH, Kim JH, Chang TT, Byun KS, Chen JJ, Jeong SH, Hu TH, Kim YS, Peng CY, Tak WY, Wang HY, Yoon SK, Sheen IS, Youn-Jae Lee, Hsu YC, Yim HJ, Tsai PC, Yeh ML, Ahn SH, Dai CY, Paik SW, Huang JF, Kim YJ, Chuang WL, Lim YS, Yu ML. Long-Term Hepatic and Extrahepatic Outcomes of Chronic Hepatitis C Patients After Sofosbuvir-Based Treatment (LONGHEAD Study). Infect Dis Ther. 2025 May;14(5):1089-1101. doi: 10.1007/s40121-025-01145-y. Epub 2025 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo evaluate the long-term outcomes including liver related morbidity, mortality and hepatocellular carcinoma (HCC) development as compared to those of historical control with interferon(IFN)-based treatment.\n\nSecondary Objective:\n\n1. To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment.\n2. To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.', 'detailedDescription': 'Primary Endpoint:\n\nTo evaluate the long-term event-free effect after sofosbuvir-based therapy, in terms of free of major liver events (including HCC, decompensation with ascites, variceal bleeding, hepatic encephalopathy, and liver-related mortality) in CHC patients.\n\nSecondary Endpoints:\n\n1. To evaluate hepatic fibrosis progression or regression in CHC patients after sofosbuvir-based therapy.\n2. To evaluate the durability of sustained viral response (SVR) in patients achieving SVR after sofosbuvir-based therapy.\n3. To evaluate long-term effect of sofosbuvir-based therapy on the extra-hepatic manifestations of the cohort. The items include mixed cryoglobulinemia, chronic kidney diseases, insulin resistance, diabetic status, cardiovascular events and dyslipidemia.\n4. To evaluate long-term effect of sofosbuvir-based therapy on quality of life on the cohort.\n\nStudy Design Prospective, longitudinal observational study\n\nStudy procedure A total of 200 patients receiving sofosbuvir based direct antiviral agents (DAAs) in the parent studies will be included for following up to 5 years. Their serological, image study and disease status description will be prospectively documented to present the long term effects of sofosbuvir-based therapy.\n\nThe presentation of illness will be specified as:\n\n1. Main hepatic complications as liver fibrosis, hepatic malignancy, liver decompensation with ascites, hepatic encephalopathy and variceal bleeding, and liver-related mortality.\n2. Life quality, extrahepatic symptoms as cryoglobulinemia, diabetes mellitus, insulin resistance, lipid profiles, renal insufficiency and other non-liver morbidities and malignancy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had ever participated the parent studies, GS-US-334-0115 or GS-US-337-0131, will be invited to participate the current study in outpatient clinic. For the patients who have participated study will be invited to participate the current study as matched historical control n our outpatient clinic, Written informed consent will be obtained after full explanation to the patients who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643) and had received at least one dose of sofosbuvir-based therapy in the parent studies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main inclusion criteria:\n\nFor Sofosbuvir-based therapy observational group:\n\n* Patients ≥ 20 of years who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643)\n* Patients who had received at least one dose of sofosbuvir-based therapy in the parent studies.\n\nWho IFN-based therapy historical controls, matched with sex, age, level of liver fibrosis and virological response:\n\n* Patients ≥ 20 of years who had received pegylated interferon plus ribavirin therapy with match of sex, age, level of liver fibrosis and virological response\n* Patients who have ever participated study will be collected as historical control.\n\nMain exclusion criteria:\n\n* Patients not qualified by the main inclusion criteria were excluded.\n\nFor Sofosbuvir-based therapy observational group:\n\n* Patients \\< 20 of years\n* Patients who are unwilling to participate the current study\n* Patients who had never participated in parent studies, GS-US-337-0131 (NCT02021656) nor GS-US-334-0115 (NCT02021643)\n* Patients who had never received at least one dose of sofosbuvir-based therapy in the parent studies.\n\nWho IFN-based therapy historical controls:\n\n* Patients \\< 20 of years\n* Patients who are unwilling to participate the current study\n* Patients who had never received pegylated interferon plus ribavirin therapy\n* Patients who did not participate study'}, 'identificationModule': {'nctId': 'NCT03042520', 'acronym': 'LONGHEAD', 'briefTitle': 'Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Long-term Hepatic and Extra-hepatic Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Interferon-free Treatment (LONGHEAD Study)', 'orgStudyIdInfo': {'id': 'irb20160082'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IFN-based therapy historical controls', 'description': 'Patients who had ever participated the parent studies, GS-US-334-0115 or GS-US-337-0131, will be invited to participate the current study in outpatient clinic. For the patients who have participated study will be invited to participate the current study as matched historical control n our outpatient clinic,', 'interventionNames': ['Other: Observation only']}, {'label': 'Sofosbuvir-based therapy observational group', 'description': '1. Patients ≥ 20 of years who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643)\n2. Patients who had received at least one dose of sofosbuvir-based therapy in the parent studies.\n\nWho IFN-based therapy historical controls, matched with sex, age, level of liver fibrosis and virological response:\n\n1. Patients ≥ 20 of years who had received peginterferon plus ribavirin therapy with match of sex, age, level of liver fibrosis and virological response\n2. Patients who have ever participated study will be collected as historical control.', 'interventionNames': ['Other: Observation only']}], 'interventions': [{'name': 'Observation only', 'type': 'OTHER', 'armGroupLabels': ['IFN-based therapy historical controls', 'Sofosbuvir-based therapy observational group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ansan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyung Joon Yim', 'role': 'CONTACT'}], 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'city': 'Asan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Suk Lim', 'role': 'CONTACT'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 36.78361, 'lon': 127.00417}}, {'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Seok Kim', 'role': 'CONTACT'}], 'facility': 'Soon Chun Hyang University Hospital Bucheon.', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Young Han', 'role': 'CONTACT'}], 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Youn-Jae Lee', 'role': 'CONTACT'}], 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won Young Tak', 'role': 'CONTACT'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ju-Hyun Kim', 'role': 'CONTACT'}], 'facility': 'Gachon University Gil Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Heo Jeong', 'role': 'CONTACT'}], 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kwan Sik Lee', 'role': 'CONTACT'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yoon Jun Kim', 'role': 'CONTACT'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Woon Paik', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sook-Hyang Jeong', 'role': 'CONTACT'}], 'facility': 'Seoul National University Bundang Hosptial', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kwan Soo Byun', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Kew Yoon', 'role': 'CONTACT'}], 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Hoon Ahn', 'role': 'CONTACT'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Changhua', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Chun Hsu', 'role': 'CONTACT'}], 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tsung-Hui Hu', 'role': 'CONTACT'}], 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wan-Long Chuang', 'role': 'CONTACT', 'email': 'waloch@kmu.edu.tw', 'phone': '0975-356064'}], 'facility': 'Kaoshiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Keelung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Rong-Nan Chien', 'role': 'CONTACT'}], 'facility': 'Keelung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.13089, 'lon': 121.74094}}, {'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Cheng-Yuan Peng', 'role': 'CONTACT'}], 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chih-Chou Chen', 'role': 'CONTACT'}], 'facility': 'Chi Mei Liouying Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Horng-Yuan Wang', 'role': 'CONTACT'}], 'facility': 'MacKay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ting-Tsung Chang', 'role': 'CONTACT'}], 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jia-Horng Kao', 'role': 'CONTACT'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chi-Jen Chu', 'role': 'CONTACT'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'I-Shyan Sheen', 'role': 'CONTACT'}], 'facility': 'Linkou Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Wan-Long Chuang', 'role': 'CONTACT', 'email': 'waloch@kmu.edu.tw', 'phone': '0975-356064'}], 'overallOfficials': [{'name': 'Ming-Lung Yu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kaoshiung Medical University Hospital'}, {'name': 'Chia-Yen Dai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaoshiung Medical University Hospital'}, {'name': 'Jee-Fu Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaoshiung Medical University Hospital'}, {'name': 'Chung-Feng Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaoshiung Medical University Hospital'}, {'name': 'Ming-Lun Yeh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaoshiung Medical University Hospital'}, {'name': 'Ching-I Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaoshiung Medical University Hospital'}, {'name': 'Ta-Wei Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaoshiung Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, {'name': 'Chi Mei Medical Hospital', 'class': 'OTHER'}, {'name': 'China Medical University, China', 'class': 'OTHER'}, {'name': 'Mackay Memorial Hospital', 'class': 'OTHER'}, {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Korea University', 'class': 'OTHER'}, {'name': 'Inje University', 'class': 'OTHER'}, {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Soon Chun Hyang University', 'class': 'OTHER'}, {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, {'name': 'Dong-A University Hospital', 'class': 'OTHER'}, {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}