Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-05-09 @ 4:05 AM
Study NCT ID:
NCT02715960
Status:
UNKNOWN
Last Update Posted:
2016-03-22
First Post:
2016-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017255', 'term': 'Acitretin'}, {'id': 'D014212', 'term': 'Tretinoin'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease control rate', 'timeFrame': '8 weeks after the first treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Psoriasis Vulgaris']}, 'descriptionModule': {'briefSummary': 'In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on the curative effect and find the relationships between genetic variants and the response of Acitretin Capsules to treatment of Psoriasis Vulgaris.', 'detailedDescription': 'Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME affect the efficacy of Acitretin Capsules; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Acitretin Capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed according to Classification criteria for Psoriasis vulgaris\n2. Patients aged 18 to 70 years (to the date of screening)\n3. PASI grade ≥7point\n4. Not treatment in the Topical corticosteroids, Immunosuppression, Biologicals agents or Tretinoin cream, Phototherapy nearly one months before enrolled.\n5. Total bilirubin \\< 1.5 x ULN, AST(SGOT)/ALT(SGPT) \\<2.5 x ULN if not liver metastases\\<5 x ULN if known liver metastases, Creatinine clearance \\<1.5 x ULN\n6. Understanding the whole process of the study, voluntary participation and signed the informed consent\n\nExclusion Criteria:\n\n1. Pregnant women, ready to pregnant or lactating women\n2. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history\n3. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers\n4. Patients with chronic diarrhea, or peptic ulcer nearly 1 year\n5. Patients suffering from malignant tumor\n6. Patients suffering from acute and chronic infectious diseases\n7. Mental disorders, history of alcohol abuse, drug or other substance abuse\n8. Other cases which researchers believe that can not enroll'}, 'identificationModule': {'nctId': 'NCT02715960', 'briefTitle': 'Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules', 'orgStudyIdInfo': {'id': '2016 AW/CSU/PS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single-arm', 'description': 'intervention: open registry, non-randomized, single-arm trial. Acitretin Capsules: 2.5 per piece.', 'interventionNames': ['Drug: Acitretin Capsules']}], 'interventions': [{'name': 'Acitretin Capsules', 'type': 'DRUG', 'otherNames': ['Tretinoin, Vitamine A Acid'], 'description': 'During The first treatment stage:10mg per day, 3 days,oral; The second stage: 20mg per day, 3 days,oral; The third stage: 30mg per day, and maintain this dose,oral.', 'armGroupLabels': ['single-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yijing He, MD, PhD', 'role': 'CONTACT', 'email': 'yijinghe@gmail.com', 'phone': '+86-1587481262'}], 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yijing He, PhD,MD', 'role': 'CONTACT', 'email': 'yijinghe@gmail.com', 'phone': '+86-1587481262'}], 'overallOfficials': [{'name': 'Xiang Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'data not entered'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yijing He', 'investigatorAffiliation': 'Central South University'}}}}