Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-01-29 @ 6:55 PM
Study NCT ID:
NCT02881034
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ribavirin Bioavailability After Telaprevir Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'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'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy', 'timeFrame': 'before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy', 'description': 'Plasma ribavirin trough concentrations were measured using a validated high-performance liquid chromatography-diode array detector method, a highly specific, sensible, and precise method of quantification'}], 'secondaryOutcomes': [{'measure': 'Change in renal function between baseline and week 4 of triple therapy', 'timeFrame': 'Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy', 'description': 'Renal function was assessed with the commonly used Modification of the Diet in Renal Disease (MDRD) study equation which allows to assess the estimated glomerular filtration rate (eGFR).'}, {'measure': 'Ribavirin plasma trough concentration at week 8 of therapy', 'timeFrame': 'at the later phase of therapy (Week 8 ± 2 weeks)'}, {'measure': 'Ribavirin plasma trough concentration after telaprevir withdrawal', 'timeFrame': 'after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))'}, {'measure': 'Renal function at week 8 of therapy', 'timeFrame': 'at the later phase of therapy (Week 8 ± 2 weeks)'}, {'measure': 'Renal function after telaprevir withdrawal', 'timeFrame': 'after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anemia', 'Antiviral Agents', 'Glomerular Filtration Rate', 'Hepatitis C', 'Ribavirin', 'Telaprevir'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hepatitis C virus infection\n* Previous non-response to pegylated-interferon/ribavirin therapy\n* Re-treatment with pegylated-interferon/ribavirin and telaprevir\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis'}, 'identificationModule': {'nctId': 'NCT02881034', 'briefTitle': 'Ribavirin Bioavailability After Telaprevir Exposure', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy', 'orgStudyIdInfo': {'id': '69HCL16_0557'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatitis C patients', 'description': 'Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir', 'interventionNames': ['Drug: Triple therapy']}], 'interventions': [{'name': 'Triple therapy', 'type': 'DRUG', 'armGroupLabels': ['Hepatitis C patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}