Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-05 @ 11:31 PM
Study NCT ID:
NCT02848105
Status:
UNKNOWN
Last Update Posted:
2016-08-01
First Post:
2016-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2016-07-26', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response', 'timeFrame': '28 days after the treatment'}], 'secondaryOutcomes': [{'measure': 'Overall response (complete + partial response)', 'timeFrame': '28 days after the treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aGVHD', 'valproic acid'], 'conditions': ['Peripheral Blood Stem Cell Transplantation', 'aGVHD']}, 'descriptionModule': {'briefSummary': 'aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1\\~2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.', 'detailedDescription': 'To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Grade II-IV aGVHD\n* No previous history of allergy to valproic acid\n* No active and severe infection\n\nExclusion Criteria:\n\n* Inclusion in other clinical trial\n* GVHD Prophylaxis with valproic acid\n* severe organ dysfunction: heart, lung, liver and kidney'}, 'identificationModule': {'nctId': 'NCT02848105', 'briefTitle': 'Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Phase II Study of Valproic Acid With Methylprenisonlone for the Treatment of Grade II-IV Acute GVHD in Patients After Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'RJH-aGVHD-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VPA+Methyl', 'description': 'VPA added to standard methylpredisonlone treatment for aGVHD', 'interventionNames': ['Drug: VPA']}], 'interventions': [{'name': 'VPA', 'type': 'DRUG', 'description': 'Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml', 'armGroupLabels': ['VPA+Methyl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiong HU, M.D.,', 'role': 'CONTACT', 'email': 'hujiong@medmail.com.cn', 'phone': '86-21-64370045'}, {'name': 'Ling Wang, M.D.,', 'role': 'CONTACT', 'email': 'cclingjar@163.com', 'phone': '86-21-64370045'}], 'facility': 'Blood & Marrow Transplantation Center, RuiJin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiong HU, M.D.,', 'role': 'CONTACT', 'email': 'hujiong@medmail.com.cn'}, {'name': 'Ling Wang, M.D.,', 'role': 'CONTACT', 'email': 'cclingjar@163.com'}], 'overallOfficials': [{'name': 'Jiong HU, M.D.,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Blood and Marrow Transplantation Program', 'investigatorFullName': 'Jiong HU', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}