Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-10 @ 2:07 PM
Study NCT ID:
NCT03260556
Status:
UNKNOWN
Last Update Posted:
2017-09-28
First Post:
2017-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pirfenidone for Progressive Fibrotic Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017565', 'term': 'Sarcoidosis, Pulmonary'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012507', 'term': 'Sarcoidosis'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093844', 'term': 'pirfenidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Placebo controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind placebo controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-27', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time until clinical worsening (TCW)', 'timeFrame': 'two years', 'description': 'TCW'}], 'secondaryOutcomes': [{'measure': 'Change in forced vital capacity (FVC)', 'timeFrame': 'two years', 'description': 'Change in forced vital capacity'}, {'measure': 'Change in CPI', 'timeFrame': 'two years', 'description': 'Change in composite physiologic index'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary fibrosis'], 'conditions': ['Sarcoidosis, Pulmonary']}, 'descriptionModule': {'briefSummary': 'Study comparing pirfenidone versus placebo for patients with advanced fibrotic sarcoidosis', 'detailedDescription': "Patients who meet the inclusion and exclusion criteria will be randomized to be treated with either placebo or pirfenidone at the current approved dosage for idiopathic pulmonary fibrosis at a 2:1 pirfenidone to placebo ratio. Patients treated with pirfenidone will be titrated using the following schedule:\n\nOne 267 mg capsules three times a day for two weeks. Two 267 mg capsules three times a day for two weeks Three 267 mg capsules three times a day thereafter Patients will be instructed to take all doses of medication with food. Dosage will be titrated on an individual basis depending on patient tolerance of medication.\n\nThose randomized to placebo will receive the same schedule using placebo tablets.\n\nBlock randomization will be done at each site. Liver function tests will be evaluated as listed above. If the patient has an abnormal liver function test, then the dose will be adjusted per the company's protocol for commercial drug."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of sarcoidosis\n* Pulmonary function testing with a Composite Physiologic Index (CPI) score of greater than 40\n* Patient must have evidence of \\>20% fibrosis on high resolution cat scan\n* Patients must be on a stable prednisone therapy for sarcoidosis for at least two months and no change in other immunosuppressives in the two months prior to entry into study\n* Age greater than 18 and less than 90.\n* Able to provide written informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patients receiving therapy for precapillary pulmonary hypertension.\n* Patients with liver disease Childs class 3 or 4\n* Patients with a left ventricular ejection fraction of less than 40%\n* Patients receiving more than 20 mg prednisone daily or its equivalent\n* Patients with massive hemoptysis within prior three months. Patients with mycetomas are eligible as long as no massive hemoptysis in prior three months.\n* Patients with clinically important co-existing disease which in the opinion of the investigator is likely to affect patient's chance for survival during the course of the study\n* Patient who is pregnant, lactating, intending to become pregnant during the study, or child bearing capacity who is not willing to use appropriate birth control methods approved by investigator"}, 'identificationModule': {'nctId': 'NCT03260556', 'acronym': 'PirFS', 'briefTitle': 'Pirfenidone for Progressive Fibrotic Sarcoidosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Pirfenidone for Progressive Fibrotic Sarcoidosis', 'orgStudyIdInfo': {'id': '2016-5706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pirfenidone', 'description': 'Pirfenidone titrated to three 267 mg tablets three times a day', 'interventionNames': ['Drug: Pirfenidone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebos', 'description': 'Placebo titrated to three tablets three times a day', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Pirfenidone', 'type': 'DRUG', 'otherNames': ['esbriet'], 'description': 'Increasing doses', 'armGroupLabels': ['Pirfenidone']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'Increasing doses', 'armGroupLabels': ['Placebos']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert P Baughman, MD', 'role': 'CONTACT', 'email': 'bob.baughman@uc.edu', 'phone': '513-584-5225'}, {'name': 'Elyse E Lower', 'role': 'CONTACT', 'email': 'ELower@ucmail.uc.edu', 'phone': '513-584-3829'}], 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Robert P Baughman, MD', 'role': 'CONTACT', 'email': 'baughmrp@ucmail.uc.edu', 'phone': '513-584-5225'}, {'name': 'Rebecca Reeves', 'role': 'CONTACT', 'email': 'Rebecca.Klein@UCHealth.com', 'phone': '513-584-5226'}], 'overallOfficials': [{'name': 'Robert P Baughman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'no plans yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert P Baughman', 'investigatorAffiliation': 'University of Cincinnati'}}}}