Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-17 @ 6:43 PM
Study NCT ID:
NCT03020004
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2017-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553752', 'term': 'danoprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yicheng.zhao@ascletis.com', 'phone': '+86057185389732', 'title': 'Clinical Trial Disclosures', 'organization': 'Ascletis Pharmaceuticals Co., Ltd'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Ascletis, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\nThe study has been completed at all study sites for at least 3 years.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Danoprevir,Ritonavir, Peg-IFN,RBV', 'description': 'Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg) for 12 weeks.\n\nDanoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily\n\nRitonavir: Ritonavir 100mg tablet administered orally twice daily\n\npeginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly\n\nRibavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg)', 'otherNumAtRisk': 70, 'otherNumAffected': 70, 'seriousNumAtRisk': 70, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 85, 'numAffected': 63}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 69, 'numAffected': 58}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'acute pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Danoprevir,Ritonavir, Peg-IFN,RBV', 'description': 'Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg) for 12 weeks.\n\nDanoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily\n\nRitonavir: Ritonavir 100mg tablet administered orally twice daily\n\npeginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly\n\nRibavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Danoprevir,Ritonavir, Peg-IFN,RBV', 'description': 'Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg) for 12 weeks.\n\nDanoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily\n\nRitonavir: Ritonavir 100mg tablet administered orally twice daily\n\npeginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly\n\nRibavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Danoprevir,Ritonavir, Peg-IFN,RBV', 'description': 'Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg) for 12 weeks.\n\nDanoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily\n\nRitonavir: Ritonavir 100mg tablet administered orally twice daily\n\npeginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly\n\nRibavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-27', 'studyFirstSubmitDate': '2017-01-05', 'resultsFirstSubmitDate': '2018-01-09', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-09', 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment', 'timeFrame': '24 weeks', 'description': 'SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Danoprevir', 'SVR12', 'Chinese HCV G1', 'non-cirrhotic'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Chronic HCV infection (≥ 6 months) ;\n* Positive HCV antibody\n* Serum HCV RNA of ≥ 1 × 104 IU/mL\n* Hepatitis C virus GT1\n* Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV\n* The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis\n* Others as specified in the detailed protocol\n\nExclusion Criteria:\n\n* Patients with Fibroscan detection value \\> 12.9 kPa, or histologic examination for liver cirrhosis patients\n* Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy\n* Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP \\> 50 ng/mL\n* Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening\n* Others as specified in the detailed protocol"}, 'identificationModule': {'nctId': 'NCT03020004', 'briefTitle': 'Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascletis Pharma Inc'}, 'officialTitle': 'A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1', 'orgStudyIdInfo': {'id': 'ASC08201502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Danoprevir,Ritonavir, Peg-IFN,RBV', 'description': 'Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg) for 12 weeks.', 'interventionNames': ['Drug: Danoprevir', 'Drug: Ritonavir', 'Drug: peginterferon alfa-2a', 'Drug: Ribavirin (RBV)']}], 'interventions': [{'name': 'Danoprevir', 'type': 'DRUG', 'otherNames': ['ASC08'], 'description': 'Danoprevir (DNV) 100mg tablet administered orally twice daily', 'armGroupLabels': ['Danoprevir,Ritonavir, Peg-IFN,RBV']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 'Ritonavir 100mg tablet administered orally twice daily', 'armGroupLabels': ['Danoprevir,Ritonavir, Peg-IFN,RBV']}, {'name': 'peginterferon alfa-2a', 'type': 'DRUG', 'otherNames': ['PegIFN'], 'description': 'PegIFN subcutaneous injection at 180 mcg weekly', 'armGroupLabels': ['Danoprevir,Ritonavir, Peg-IFN,RBV']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Ribasphere®'], 'description': 'Ribavirin (RBV)1000/1200 mg/day (bodyweight\\<75/≥75 kg)', 'armGroupLabels': ['Danoprevir,Ritonavir, Peg-IFN,RBV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Huoling Tang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ascletis Pharmaceuticals Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascletis Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}