Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT01998620
Status:
UNKNOWN
Last Update Posted:
2014-05-29
First Post:
2013-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D002779', 'term': 'Cholestasis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2013-11-14', 'studyFirstSubmitQcDate': '2013-11-25', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'levels of serum total bilirubin declined from baseline', 'timeFrame': '2 weeks', 'description': 'levels of serum total bilirubin declined from baseline'}, {'measure': 'Alkaline Phosphatase', 'timeFrame': '10 weeks', 'description': 'Alkaline Phosphatase'}, {'measure': 'Gamma-Glutamyl Transpeptidase', 'timeFrame': '10 weeks', 'description': 'Gamma-Glutamyl Transpeptidase'}], 'secondaryOutcomes': [{'measure': 'level of serum direct bilirubin decline from baseline', 'timeFrame': '2 weeks, 6 weeks, 10 weeks', 'description': 'level of serum direct bilirubin decline from baseline'}, {'measure': 'level of serum bile acids decline from baseline', 'timeFrame': '2 weeks, 6 weeks, 10 weeks', 'description': 'level of serum bile acids decline from baseline'}, {'measure': 'glutamic pyruvic transaminase', 'timeFrame': '2 weeks, 6 weeks, 10 weeks', 'description': 'glutamic pyruvic transaminase'}, {'measure': 'glutamic oxaloacetic transaminase', 'timeFrame': '2 weeks, 6 weeks, 10 weeks', 'description': 'glutamic oxaloacetic transaminase'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis B', 'Cholestasis'], 'conditions': ['Hepatitis B', 'Cholestasis']}, 'descriptionModule': {'briefSummary': 'This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.', 'detailedDescription': 'evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. from 18-65 years old\n2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)\\>6 months, and now HBsAg or HBV DNA(+)\n3. with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP\\>1.5ULN and GGT\\>3ULN or STB\\>2ULN\n\nExclusion Criteria:\n\n1. liver mass, liver carcinoma\n2. liver failure\n3. non-hepatic diseases caused jaundice\n4. obstructive jaundice'}, 'identificationModule': {'nctId': 'NCT01998620', 'briefTitle': 'Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhejiang Hisun Pharmaceutical Co. Ltd.'}, 'officialTitle': 'Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis', 'orgStudyIdInfo': {'id': 'XMX-HBV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ademetionine 1', 'description': 'Ademetionine 2000mg', 'interventionNames': ['Drug: Ademetionine 1']}, {'type': 'EXPERIMENTAL', 'label': 'Ademetionine 2', 'description': 'Ademetionine 1000mg', 'interventionNames': ['Drug: Ademetionine 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ademetionine 3', 'description': 'no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks', 'interventionNames': ['Drug: Ademetionine 3']}], 'interventions': [{'name': 'Ademetionine 2', 'type': 'DRUG', 'description': 'Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks', 'armGroupLabels': ['Ademetionine 2']}, {'name': 'Ademetionine 1', 'type': 'DRUG', 'description': 'Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks', 'armGroupLabels': ['Ademetionine 1']}, {'name': 'Ademetionine 3', 'type': 'DRUG', 'description': 'no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks', 'armGroupLabels': ['Ademetionine 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Chen, Doctor', 'role': 'CONTACT', 'email': 'chenlian@shaphl.org', 'phone': '00862137990333'}], 'facility': 'Public Health Clinical Center Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Liang Chen', 'role': 'CONTACT', 'email': 'chenlian@shaphl.org', 'phone': '00862137990333'}], 'overallOfficials': [{'name': 'Liang Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Public Health Clinical Center Affiliated to Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Hisun Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}