Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03549832
Status:
COMPLETED
Last Update Posted:
2019-03-19
First Post:
2018-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'D000069616', 'term': 'Simeprevir'}, {'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C586094', 'term': 'ombitasvir'}], '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'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-17', 'studyFirstSubmitDate': '2018-05-27', 'studyFirstSubmitQcDate': '2018-05-27', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SVR rate', 'timeFrame': '12 weeks', 'description': 'The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCV', 'DAAs', 'Non-responder'], 'conditions': ['HCV Coinfection']}, 'referencesModule': {'references': [{'pmid': '26083155', 'type': 'RESULT', 'citation': 'Gutierrez JA, Lawitz EJ, Poordad F. Interferon-free, direct-acting antiviral therapy for chronic hepatitis C. J Viral Hepat. 2015 Nov;22(11):861-70. doi: 10.1111/jvh.12422. Epub 2015 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.', 'detailedDescription': 'HCV management with new DAAs is now promising. However, many cases reporting treatment failure either non-responder or relapse to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in a multicenter open-labeled randomized trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with proven CHC genotype 4\n* 18 years old or more,\n* prior HCV treatment failure to sofosbuvir /daclatasvir\n* compensated liver disease.\n\nExclusion Criteria:\n\n* Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.'}, 'identificationModule': {'nctId': 'NCT03549832', 'briefTitle': 'Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial)', 'orgStudyIdInfo': {'id': 'IRB17300204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sof/sim/dac', 'description': 'Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Simeprevir', 'Drug: Daclatasvir', 'Drug: Ribavirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sof/omb/parit', 'description': 'Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Ribavirin', 'Drug: Ombitasvir/paritaprevir/ritonavir']}], 'interventions': [{'name': 'Sofosbuvir', 'type': 'DRUG', 'description': 'Sofosbuvir 400 mg oral pills', 'armGroupLabels': ['sof/omb/parit', 'sof/sim/dac']}, {'name': 'Simeprevir', 'type': 'DRUG', 'description': 'Simeprevir 150 mg oral pills', 'armGroupLabels': ['sof/sim/dac']}, {'name': 'Daclatasvir', 'type': 'DRUG', 'description': 'Daclatasvir 60 mg oral pills', 'armGroupLabels': ['sof/sim/dac']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'Ribavirin 200 mg oral pills', 'armGroupLabels': ['sof/omb/parit', 'sof/sim/dac']}, {'name': 'Ombitasvir/paritaprevir/ritonavir', 'type': 'DRUG', 'description': 'Ombitasvir/paritaprevir/ritonavir oral pills', 'armGroupLabels': ['sof/omb/parit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hopsital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mohamed Mekky, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sohag University', 'class': 'OTHER'}, {'name': 'South Valley University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Professor', 'investigatorFullName': 'Mohamed Abdelsabour Mekky', 'investigatorAffiliation': 'Assiut University'}}}}