Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-22 @ 2:30 AM
Study NCT ID:
NCT04111367
Status:
UNKNOWN
Last Update Posted:
2019-10-01
First Post:
2019-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients
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': 'D000069474', 'term': 'Sofosbuvir'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-30', 'studyFirstSubmitDate': '2019-09-29', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 is defined as HCV RNA \\< the lower limit of quantification (LLOQ; ie, \\< 15 IU/mL) 12 weeks following the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 is defined as HCV RNA \\< LLOQ at 4 weeks following the last dose of study drug.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection']}, 'descriptionModule': {'briefSummary': 'This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir in patients with Hepatitis C (HCV) genotype2,3,6. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHepatitis C virus (HCV) genotype 2,3,6 infection (confirmed at screening). HCV RNA greater than 10,000 IU/mL at screening. Participant must be willing and able to comply with the protocol requirements. weight was more than 40 kg. age is between 18-75,either sex.\n\nExclusion Criteria:\n\nCo-infection with hepatitis B virus or human immunodeficiency virus (HIV). Infection with HCV non-genotype 2,3,6,or Infection with mixed genotype,or Genotype cannot be confirmed.\n\nMedical history of major functional organ transplantation. Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).\n\nParticipation in a clinical study within 3 months prior to first dose'}, 'identificationModule': {'nctId': 'NCT04111367', 'briefTitle': 'Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ginkgopharma CO., LTD'}, 'officialTitle': 'A Phase IIa, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 2,3,6 Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': 'GP205-1901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genotype 2 and 6 Subjects', 'description': 'Genotype 2 and 6 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12', 'interventionNames': ['Drug: Seraprevir', 'Drug: Sofosbuvir']}, {'type': 'EXPERIMENTAL', 'label': 'Genotype 3 Subjects', 'description': 'Genotype 3 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 24', 'interventionNames': ['Drug: Seraprevir', 'Drug: Sofosbuvir']}], 'interventions': [{'name': 'Seraprevir', 'type': 'DRUG', 'otherNames': ['GP205'], 'description': 'Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12，the other group will receive the same dose for 24 weeks.', 'armGroupLabels': ['Genotype 2 and 6 Subjects', 'Genotype 3 Subjects']}, {'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['sovaldi'], 'description': 'Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12,the other group will receive the same dose for 24 weeks.', 'armGroupLabels': ['Genotype 2 and 6 Subjects', 'Genotype 3 Subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huichun Xing', 'role': 'CONTACT'}], 'facility': 'Beijing Ditan Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Liuchow', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng Wen', 'role': 'CONTACT'}], 'facility': 'Liuzhou General Hospital', 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junqi Niu', 'role': 'CONTACT', 'email': 'junqiniu@aliyun.com', 'phone': '0431-88782013'}], 'facility': 'The first hospital of JILIN University.', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Guangxi', 'state': 'Nanning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Minghua Su', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital Of Guangxi Medical University', 'geoPoint': {'lat': 32.09142, 'lon': 120.24205}}], 'centralContacts': [{'name': 'Junqi Niu', 'role': 'CONTACT', 'email': 'junqiniu@aliyun.com', 'phone': '0431-88782013'}], 'overallOfficials': [{'name': 'Xuegang Wu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ginkgo Pharma Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ginkgopharma CO., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}