Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-01 @ 3:15 PM
Study NCT ID:
NCT03623568
Status:
WITHDRAWN
Last Update Posted:
2019-06-03
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000612853', 'term': 'glecaprevir'}, {'id': 'C000622691', 'term': 'pibrentasvir'}, {'id': 'C000654128', 'term': 'glecaprevir and pibrentasvir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'did not move forward with IRB approval, competing study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2021-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-30', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Undetectable HCV RNA in blood', 'timeFrame': '12 weeks post treatment', 'description': 'Negative HCV viral RNA at 12 weeks after the last dose of treatment as determined by blood test'}], 'secondaryOutcomes': [{'measure': 'Safety (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation)', 'timeFrame': '12 weeks post treatment', 'description': 'Safety of Mavyret therapy in the kidney transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.'}, {'measure': 'Tolerability (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation', 'timeFrame': '12 Weeks post treatment', 'description': 'Tolerability of Mavyret therapy in the kidney transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD', 'HCV', 'Hepatitis C', 'Transplant'], 'conditions': ['Kidney Failure', 'Kidney Diseases', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.', 'detailedDescription': 'The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after kidney transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Met MGH transplant center criteria and already listed for kidney transplant\n* No available living kidney donor\n* Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.\n* On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate \\<15mL/min/1.73m2 at the time of screening\n* Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method\n* Weigh at least 50kg\n* Serum ALT within normal limits with no history of liver disease\n* Able to sign informed consent\n\nExclusion Criteria:\n\n* AB blood type\n* BMI \\> 35\n* Any liver disease in recipient\n* Pregnant or nursing (lactating) women\n* Known allergy or intolerance to tacrolimus that would require administration of cyclosporine rather than tacrolimus given the known drug-drug interaction between cyclosporine and Mavyret\n* Cardiomyopathy (LV ejection fraction \\< 50%)\n* Albumin \\< 3g/dl or platelet count \\< 75 x 103/mL\n* Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist\n* Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist\n* HCV RNA positive\n* Hepatitis B surface antigen positive\n* Any known liver disease or elevated liver transaminases\n* Patients with primary focal segmental glomerulosclerosis (FSGS), FSGS recurring after previous transplant, or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or the investigator team\n* Any contra-indication to kidney transplantation per MGH center protocol\n* Patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives."}, 'identificationModule': {'nctId': 'NCT03623568', 'briefTitle': 'Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant', 'orgStudyIdInfo': {'id': '2018P001077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV', 'description': '12 weeks of treatment with Mavyret', 'interventionNames': ['Drug: glecaprevir/pibrentasvir tablets']}], 'interventions': [{'name': 'glecaprevir/pibrentasvir tablets', 'type': 'DRUG', 'otherNames': ['Mavyret'], 'description': '12 weeks of treatment with Mavyret', 'armGroupLabels': ['Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Raymond T Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Anticipate data would be available to share within 6 months after the final patient completes the study.', 'ipdSharing': 'YES', 'description': 'Anticipate to share coded data with collaborators', 'accessCriteria': 'Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raymond T. Chung, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Hepatology', 'investigatorFullName': 'Raymond T. Chung, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}