Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-07 @ 9:19 PM
Study NCT ID:
NCT03068234
Status:
UNKNOWN
Last Update Posted:
2017-03-01
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093844', 'term': 'pirfenidone'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-02-24', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rodnan Skin Score (mRSS）', 'timeFrame': 'Week 52', 'description': 'A semi-quantitative score for skin fibrosis of every subjects'}], 'secondaryOutcomes': [{'measure': 'Modified Rodnan Skin Score', 'timeFrame': 'Week 24', 'description': 'A semi-quantitative score for skin fibrosis of every subjects'}, {'measure': 'Assessment of chest CT', 'timeFrame': 'Week 52', 'description': 'Semi-quantitative scale for fibrotic changes in chest CT images from an individual patient'}, {'measure': 'Assessment of chest CT', 'timeFrame': 'Week 24', 'description': 'Semi-quantitative scale for fibrotic changes in chest CT images from an individual patient'}, {'measure': 'Forced vital capacity', 'timeFrame': 'Week 52', 'description': 'A marker for lung function that may decrease with pulmonary fibrosis'}, {'measure': 'Forced vital capacity', 'timeFrame': 'Week 24', 'description': 'A marker for lung function that may decrease with pulmonary fibrosis'}, {'measure': 'Diffusing capacity', 'timeFrame': 'Week 52', 'description': 'Another marker for lung function that may decrease with pulmonary fibrosis'}, {'measure': 'Diffusing capacity', 'timeFrame': 'Week 24', 'description': 'Another marker for lung function that may decrease with pulmonary fibrosis'}, {'measure': '6 minute walk test', 'timeFrame': 'Week 52', 'description': 'A simple, well-accepted and quantitative clinical exam to test heart and lung function'}, {'measure': '6 minute walk test', 'timeFrame': 'Week 24', 'description': 'A simple, well-accepted and quantitative clinical exam to test heart and lung function'}, {'measure': 'Hand function assessment', 'timeFrame': 'Week 52', 'description': 'Hand function will be measured by Cochin Hand Function Scale'}, {'measure': 'Hand function assessment', 'timeFrame': 'Week 24', 'description': 'Hand function will be measured by Cochin Hand Function Scale'}, {'measure': 'Proportion of subjects with increased mRSS', 'timeFrame': 'Week 52', 'description': 'Proportion of subjects with ∆mRSS≥5'}, {'measure': 'Proportion of subjects with increased mRSS', 'timeFrame': 'Week 24', 'description': 'Proportion of subjects with ∆mRSS≥5'}, {'measure': 'Quality of life', 'timeFrame': 'Week 52', 'description': 'Assessed by the health assessment questionnaire disability index'}, {'measure': 'Quality of life', 'timeFrame': 'Week 24', 'description': 'Assessed by the health assessment questionnaire disability index'}, {'measure': 'Safety and Tolerability', 'timeFrame': 'Week 52', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}, {'measure': 'Safety and Tolerability', 'timeFrame': 'Week 24', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. The primary outcome of this study is improvement of skin fibrosis.', 'detailedDescription': 'All patients enrolled should suffer from moderate to severe skin fibrosis at the screening stage.\n\nThe study period is 52 week. The study contains two stages, a 24-week blind stage following with open stage for another 24-week period of time. Subjects will receive pirfenidone or placebo randomized in the first 24-week and will all receive pirfenidone treatment in the second 24-week, with of combination of low dose steroids.\n\nThe secondary outcomes of this study include but not limit to safety, improvement of lung fibrosis and digital ulcer burden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfill EULAR/ACR classification criteria (2013) for systemic sclerosis (SSc).\n* Subjects must have mRSS≥10 at screening stage\n* Subjects must have signs of fibrosis in their chest CT at screening stage\n* If a subject has received treatments before, it should be stable at least 3 months until screening and with no significant efficacy (ΔmRSS≤-2)\n\nExclusion Criteria:\n\n* Subjects with other connective tissue diseases overlapping with SSc\n* Subjects with skin atrophy as the main cutaneous manifestation\n* Subjects with active digital ulcers or gangrene\n* Active severe SSc-driven renal disease or heart dysfunction at screening\n* Subjects with significant hematologic abnormalities\n* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level\n* Clinically significant active infection including ongoing and chronic infections\n* History of human immunodeficiency virus (HIV)\n* Confirmed Positive tests for hepatitis B or positive test for hepatitis C\n* Active tuberculosis\n* Live or attenuated vaccine within 4 weeks prior to screening\n* Subjects with significant hematologic abnormalities'}, 'identificationModule': {'nctId': 'NCT03068234', 'briefTitle': 'Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'A Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic Sclerosis', 'orgStudyIdInfo': {'id': '[2017]17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pirfenidone group', 'description': 'The subjects will receive pirfenidone from 200mg three times a day, oral administrated, with low dose steroids.', 'interventionNames': ['Drug: Pirfenidone', 'Drug: Steroids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The subjects will receive placebo within first 24-week, and pirfenidone 200mg three times a day for the second 24-week, with low dose steroids.', 'interventionNames': ['Drug: Pirfenidone', 'Drug: Placebo oral capsule', 'Drug: Steroids']}], 'interventions': [{'name': 'Pirfenidone', 'type': 'DRUG', 'description': 'A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.', 'armGroupLabels': ['Control group', 'Pirfenidone group']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo for pirfenidone capsule', 'armGroupLabels': ['Control group']}, {'name': 'Steroids', 'type': 'DRUG', 'description': 'Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis', 'armGroupLabels': ['Control group', 'Pirfenidone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'RenJi Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}