Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-03-27 @ 8:48 AM
Study NCT ID:
NCT01908335
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2013-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C571406', 'term': 'PEG-IFN-SA'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-16', 'studyFirstSubmitDate': '2013-07-23', 'studyFirstSubmitQcDate': '2013-07-23', 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cEVR (complete early virologic response)', 'timeFrame': 'weeks 12 of study therapy', 'description': 'defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 12'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who had undetectable plasma HCV RNA', 'timeFrame': 'weeks 4, 24, 48 of study therapy and 24 weeks after the end of treatment'}, {'measure': 'HCV RNA load reduction', 'timeFrame': 'weeks 4, 12, 24, 48 of study therapy and 24 weeks after the end of treatment'}, {'measure': 'eRVR ( extended rapid virologic response)', 'timeFrame': 'weeks 4 and 12 of study therapy', 'description': 'defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 4 and 12'}, {'measure': 'Breakthrough', 'timeFrame': 'weeks 24, 48 of study therapy', 'description': 'defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA)'}, {'measure': 'Relapse', 'timeFrame': '12 and 24 weeks after the end of treatment', 'description': 'defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after then'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['interferon', 'ribavirin', 'virological response'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This dose-escalating study is to evaluate the efficacy and the safety of different doses of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated with Interferon(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.', 'detailedDescription': 'Total 200 subjects will be randomized and enrolled into four groups proportionally receiving experimental drug of high dose, middle dose, low dose and positive-control drug. Treatment duration will be 24 or 48 weeks corresponding to different HCV genotype, genotype 2,3 and non-genotype2,3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18- 65 years\n* Body Mass Index (BMI) 18-30\n* Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year 2004)\n* Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive anti-HCV antibody\n* Female subjects of childbearing age with no history of menopause and negative pregnancy test, both female and male( including their partners ) subjects were required to conduct adequate contraception since screening until the 6 months after treatment\n* Volunteered to participate in this study, understood and signed an informed consent\n\nExclusion Criteria:\n\n* Previous IFN treated patients\n* Co-infection with HAV, HBV, HEV, EBV, CMV and HIV\n* Evidences of hepatic decompensation, including but not limited to serum total bilirubin\\> 2 times the upper limit of normal (ULN); serum albumin \\<35g/L; prothrombin activity (PTA) \\<60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade\n* Hepatotoxic drugs was used for a long time within past 6 months\n* Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP\\> l00ng/ml, suspicious liver nodules by imaging examinations\n* Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.\n* White blood cell count \\<3×109/L; Neutrophil count\\<1.5×109/L; platelet count\\<90×109/L; hemoglobin below the lower limit of normal\n* Serum creatinine not within the normal range\n* Serum creatine kinase\\> 3 ULN\n* Positive thyroid antibodies (A-TPO, A-TG)\n* Therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1 etc. within past 6 months or an anticipated usage during the period of study\n* Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs\n* Severe autoimmune diseases; psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.); Serious blood disorders (all kinds of anemia, hemophilia, etc.); Severe kidney disease (chronic kidney disease, renal insufficiency, etc.); poorly controlled digestive diseases; endocrine disorders such as thyroid disease and diabetes; severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.); cardiovascular diseases (hypertension, uncontrolled coronary atherosclerotic heart disease, heart failure, etc.); retinal disease; malignancies; or unsuitable for study considered by clinician\n* Function organs transplant\n* Evidence of alcohol or drug abuse (average alcohol consumption male\\> 40g / day, female\\> 20g / day)\n* Pregnant or lactating women\n* Usage of prohibition drugs in this study\n* Participated in other clinical trials 3 months prior to the screening\n* Unwilling to sign the informed consent and adhere to treatment requirements\n* Other conditions not suitable for study judged by investigators"}, 'identificationModule': {'nctId': 'NCT01908335', 'briefTitle': 'A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Kawin Technology Share-Holding Co., Ltd.'}, 'officialTitle': 'Phase Ⅱ, Multi-center, Randomized, Open-label, Parallel-group, Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'KAWIN-002-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A (PEG-IFN-SA /RBV low dose)', 'description': 'PEG-IFN-SA 0.75μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\\<75kg，1000mg/d；BW≥75kg，1200mg/d）', 'interventionNames': ['Drug: PEG-IFN-SA /RBV low dose']}, {'type': 'EXPERIMENTAL', 'label': 'B (PEG-IFN-SA /RBV middle dose)', 'description': 'PEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\\<75kg，1000mg/d；BW≥75kg，1200mg/d）', 'interventionNames': ['Drug: PEG-IFN-SA /RBV middle dose']}, {'type': 'EXPERIMENTAL', 'label': 'C (PEG-IFN-SA /RBV high dose)', 'description': 'PEG-IFN-SA 2.0μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\\<75kg，1000mg/d；BW≥75kg，1200mg/d）', 'interventionNames': ['Drug: PEG-IFN-SA /RBV high dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D (Pegasys /RBV)', 'description': 'Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\\<75kg，1000mg/d；BW≥75kg，1200mg/d）', 'interventionNames': ['Drug: Pegasys /RBV']}], 'interventions': [{'name': 'PEG-IFN-SA /RBV low dose', 'type': 'DRUG', 'description': '24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3', 'armGroupLabels': ['A (PEG-IFN-SA /RBV low dose)']}, {'name': 'PEG-IFN-SA /RBV middle dose', 'type': 'DRUG', 'description': '24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3', 'armGroupLabels': ['B (PEG-IFN-SA /RBV middle dose)']}, {'name': 'PEG-IFN-SA /RBV high dose', 'type': 'DRUG', 'description': '24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3', 'armGroupLabels': ['C (PEG-IFN-SA /RBV high dose)']}, {'name': 'Pegasys /RBV', 'type': 'DRUG', 'description': '24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3', 'armGroupLabels': ['D (Pegasys /RBV)']}]}, 'contactsLocationsModule': 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22.54554, 'lon': 114.0683}}, {'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Third Affiliated Hospital, Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Xinxiang', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xinxiang Medical University', 'geoPoint': {'lat': 35.19033, 'lon': 113.80151}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College Huazhong University of Science ＆ Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union hospital, Tongji Medical College Huazhong University of Science ＆ Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': 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{'lat': 43.88, 'lon': 125.32278}}, {'city': 'Yanji', 'state': 'Jilin', 'country': 'China', 'facility': 'Yanbian University Hospital (Yanbian Hospital)', 'geoPoint': {'lat': 42.88825, 'lon': 129.50241}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': "The Sixth People's Hospital of Shenyang", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'First Affiliated Hospital Of Medical College of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Second Affiliated Hospital Of Medical College of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Tangdu Hospital , , Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Jinan Infectious Disease Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong university', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Qingdao Municipal Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'The First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Academy of Medical Science ＆Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'The First Teaching Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Xixi Hospital of Hangzhou', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Beijing', 'country': 'China', 'facility': '302 Military Hospital of China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Ditan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Youan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Youyi Hospital, capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'General Hospital of Beijing Military Region', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Chongqing Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Daping Hospital, Research Institute of Surgery Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijing Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Infectious Disease Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Cheng jun, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Ditan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Kawin Technology Share-Holding Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice president', 'investigatorFullName': 'Cheng jun', 'investigatorAffiliation': 'Beijing Kawin Technology Share-Holding Co., Ltd.'}}}}