Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-01 @ 6:29 AM
Study NCT ID:
NCT02946034
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2016-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654128', 'term': 'glecaprevir and pibrentasvir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Chung.Raymond@mgh.harvard.edu', 'phone': '617-726-5925', 'title': 'Dr. Raymond Chung', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our study has several limitations. Our pilot trial was limited by the small number of patients enrolled. Additionally, two subjects were lost to follow-up, decreasing the power of our analysis comparing pre- and post-treatment kidney function and biomarkers. Thus, the analysis presented is descriptive in nature. The analysis is limited by the absence of a control group.'}}, 'adverseEventsModule': {'timeFrame': 'Each patient was followed for one year after initiation of treatment.', 'description': 'Adverse events data collection was done at each study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'muscle pain in leg', 'notes': 'Reported at week 12 visit, deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'notes': 'Observed at week 12 visit, deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'notes': 'For one patient, reported at week 8 visit, deemed possibly related to study drug.\n\nFor another, reported at week 4 visit, deemed possibly related to study drug.\n\nFor another, reported at week 2 visit, deemed possibly related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cryoglobulinemia', 'notes': 'Observed at week 1 visit, deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'slow ventricular response', 'notes': 'Observed at week 8 visit and 12-weeks post treatment, deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'high potassium', 'notes': 'Observed at week 1 of treatment, deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stroke', 'notes': 'Occurred 30 weeks post-treatment, was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'notes': 'Occurred 19 weeks post-treatment, was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall / loss of consciousness', 'notes': 'Occurred 22 weeks post-treatment, was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'notes': 'Occurred 29 weeks post-treatment, was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cryoglobulinemic glomerulonephritis', 'notes': 'Occurred week 2 of treatment, was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart block', 'notes': 'Occurred week 5 of treatment, deemed possibly related to study drug (digoxin interaction with Mavyret).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive emergency', 'notes': 'Occurred 39 weeks post-treatment, was deemed not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients did not have urine TNF-alpha tested at these timepoints.'}, {'type': 'PRIMARY', 'title': 'Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin\n\n8 or 12 week therapy with Mavyret\n\nViekira Pak ± ribavirin: 12 weeks treatment with AbbVie Viekira Pak ± ribavirin\n\nMavyret: 8 or 12 weeks treatment with AbbVie Mavyret'}], 'classes': [{'categories': [{'measurements': [{'value': '5.73', 'spread': '12.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients did not have urine IL-6 tested at these timepoints.'}, {'type': 'PRIMARY', 'title': 'Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.67', 'spread': '42.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients did not have plasma TNF-alpha tested at these timepoints.'}, {'type': 'PRIMARY', 'title': 'Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients)'}], 'classes': [{'categories': [{'measurements': [{'value': '-394.57', 'spread': '657.80', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 Weeks 52 Weeks 52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients did not have plasma IP-10 tested at these timepoints.'}, {'type': 'PRIMARY', 'title': 'Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.01', 'spread': '29.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients did not have plasma IFN-gamma tested at these timepoints.'}, {'type': 'PRIMARY', 'title': 'Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.94', 'spread': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients did not have plasma IL-6 tested at these timepoints.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by number of patients who suffered adverse events (serious or otherwise) deemed to be related to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavryet (8 patients)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients did not have hepatitis C checked after 12-weeks post-treatment; thus, we cannot definitively determine that they achieved SVR12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Viekira Pak ± Ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin (2 patients)\n\n8 or 12 week therapy with Mavyret (8 patients)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis C genotype', 'classes': [{'title': 'Genotype 1a', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Genotype 1b', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Genotype 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Genotype 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Genotype 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline estimated glomerular filtration rate (eGFR)', 'classes': [{'title': '60-89 mL/min/1.73m2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '30-59 mL/min/1.73m2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '<30 mL/min/1.73m2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Two patients received AbbVie Viekira Pak ± ribavirin, and eight patients received Abbvie Mavyret (glecaprevir/pibrentasvir).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-25', 'size': 285444, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-08T13:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This a single-arm study. Initially, Viekira Pak was available through Abbvie. However, once Mavyret became available, it supplanted Viekira Pak as the study medication.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2016-10-21', 'resultsFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-05', 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment', 'timeFrame': '52 Weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.'}, {'measure': 'Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment', 'timeFrame': '52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.'}, {'measure': 'Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment', 'timeFrame': '52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.'}, {'measure': 'Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment', 'timeFrame': '52 Weeks 52 Weeks 52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.'}, {'measure': 'Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment', 'timeFrame': '52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.'}, {'measure': 'Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment', 'timeFrame': '52 weeks', 'description': 'Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.\n\nTo calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)', 'timeFrame': '12 weeks', 'description': 'Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by number of patients who suffered adverse events (serious or otherwise) deemed to be related to study drug.'}, {'measure': 'Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)', 'timeFrame': '24 weeks', 'description': 'Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD', 'HCV'], 'conditions': ['Chronic Kidney Disease', 'Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.', 'detailedDescription': 'The objective of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin or Glecaprevir / Pibrentasvir (referred to as Mavyret) for adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. During the course of this prospective, single arm treatment trial, we will measure currently accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with eradication of HCV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ≥ 18 year of age\n2. HCV genotype 1 ≥ 1000 IU/mL\n3. 6\\. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation\n\nExclusion Criteria:\n\n1. Pregnant or lactating females\n2. Uncontrolled depression or psychiatric disease\n3. History or presence of any form of cancer within 3 years of enrollment\n4. Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.\n5. Uncontrolled cardiovascular or pulmonary disease\n6. Experiencing symptoms attributed to uremia\n7. Anticipated need to begin renal replacement therapy in the next 6 months\n8. History of kidney transplant'}, 'identificationModule': {'nctId': 'NCT02946034', 'briefTitle': 'Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Safety, Efficacy, and Changes in Traditional and Novel Biomarkers of Kidney Function in Patients With Hepatitis C and Advanced Chronic Kidney Disease Treated With Abbvie Viekira Pak or Mavyret Regimen', 'orgStudyIdInfo': {'id': '2016P001822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Viekira Pak ± ribavirin or Mavyret', 'description': '12 week therapy with Viekira Pak ± ribavirin\n\n8 or 12 week therapy with Mavyret', 'interventionNames': ['Drug: Viekira Pak ± ribavirin', 'Drug: Mavyret']}], 'interventions': [{'name': 'Viekira Pak ± ribavirin', 'type': 'DRUG', 'otherNames': ['AbbVie 3D regimen'], 'description': '12 weeks treatment with AbbVie Viekira Pak ± ribavirin', 'armGroupLabels': ['Viekira Pak ± ribavirin or Mavyret']}, {'name': 'Mavyret', 'type': 'DRUG', 'description': '8 or 12 weeks treatment with AbbVie Mavyret', 'armGroupLabels': ['Viekira Pak ± ribavirin or Mavyret']}]}, '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': {'ipdSharing': 'YES', 'description': 'Results data will be shared with the study sponsor and publication of data is anticipated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Hepatology, Massachusetts General Hospital', 'investigatorFullName': 'Raymond Chung', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}