Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-11 @ 12:46 AM
Study NCT ID:
NCT03389061
Status:
WITHDRAWN
Last Update Posted:
2020-12-07
First Post:
2017-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}, {'id': 'D000069474', 'term': 'Sofosbuvir'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Bio-equivalence Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of patients who are eligible for inclusion: less patients on treatment and not using epclusa.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'Up to 24 hours after administration'}, {'measure': 'Cmax', 'timeFrame': 'one dosing interval after administration of SOF/VEL (up to 24 hours)'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'During the entire conduct of the study, maximum of two weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epclusa', 'Pharmacokinetics', 'Crushing'], 'conditions': ['HCV']}, 'referencesModule': {'references': [{'pmid': '32156618', 'type': 'RESULT', 'citation': 'van Seyen M, Samson AD, Cullen L, Eastick K, Knol H, Colbers A, Burger DM. Crushed application of sofosbuvir and velpatasvir in a patient with swallowing disorder. Int J Antimicrob Agents. 2020 Jun;55(6):105934. doi: 10.1016/j.ijantimicag.2020.105934. Epub 2020 Mar 7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg.\n\nFor patients with swallowing difficulties, administration of whole tablets can be problematic. In addition, HCV patients that are hospitalized (at intensive care units) due to severe illness (co-infections/ liver failure) might not be able to swallow medication. Therefore it is useful to know whether it is possible to administer SOF/VEL through a different route, like a feeding tube.\n\nIn daily practice, information about the safety and efficacy of crushed tablets is lacking which might result in interruption or discontinuation of expensive HCV therapy. However, it is not recommended to interrupt treatment because there is no evidence about the efficacy of the therapy after discontinuation (and restart).\n\nCurrently, patients and healthcare professionals are crushing SOF/VEL tablets without information about efficacy and safety. Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs.\n\nIt is important to know whether pharmacokinetic parameters are influenced by crushing of tablets; both a decrease and an increase in exposure may occur. A decrease of the plasma concentrations of SOF and/or VEL potentially reduces the therapeutic effect of the drugs. Higher doses or switching to other HCV-drugs might be needed. In contrast, in case a higher Cmax,ss and/or exposure occurs there might be an increased risk of toxicity.\n\nAs a result, crushing the drug is a contra-indication based on the available data.\n\nTherefore this study will be conducted to investigate whether a crushed SOF/VEL tablet is bioequivalent to SOF/VEL as a whole tablet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with SOF/VEL treatment for the treatment of chronic HCV genotype 1 through 6.\n2. Patient is at least 18 at the day of screening.\n3. Patient is able and willing to sign the Informed Consent Form.\n4. Patient is able and willing to follow protocol requirements.\n\nExclusion Criteria:\n\n1. Pregnant female (as confirmed by an hCG urine test performed at screening) or breast-feeding female.\n2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.\n3. Inability to understand the nature and extent of the study and the procedures required.\n4. Clinically relevant low hemoglobin concentration at screening judged by the patient's own hepatologist."}, 'identificationModule': {'nctId': 'NCT03389061', 'acronym': 'CRUSADE-1', 'briefTitle': 'Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet', 'orgStudyIdInfo': {'id': 'UMCN-AKF 16.06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sofosbuvir/velpatasvir tablet', 'description': 'Single-dose sofosbuvir/velpatasvir as a whole tablet in a fasted state.', 'interventionNames': ['Drug: sofosbuvir/velpatasvir tablet']}, {'type': 'EXPERIMENTAL', 'label': 'sofosbuvir/velpatasvir crushed', 'description': 'Single-dose crushed sofosbuvir/velpatasvir in a fasted state.', 'interventionNames': ['Drug: sofosbuvir/velpatasvir crushed']}], 'interventions': [{'name': 'sofosbuvir/velpatasvir tablet', 'type': 'DRUG', 'description': 'Single-dose SOF/VEL as a whole tablet in a fasted state.', 'armGroupLabels': ['sofosbuvir/velpatasvir tablet']}, {'name': 'sofosbuvir/velpatasvir crushed', 'type': 'DRUG', 'description': 'Single-dose crushed SOF/VEL in a fasted state.', 'armGroupLabels': ['sofosbuvir/velpatasvir crushed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bonn', 'country': 'Germany', 'facility': 'University of Bonn, Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Hospital', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud university medical center Department of GI tract', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}