Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT02992457
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D000069616', 'term': 'Simeprevir'}, {'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'C585405', 'term': 'paritaprevir'}, {'id': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}, {'id': 'D016879', 'term': 'Salvage Therapy'}], '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': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2016-12-10', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with sustained virological response.', 'timeFrame': '2 months', 'description': 'The number of patients achieving SVR'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '32356185', 'type': 'DERIVED', 'citation': 'Said EM, Abdulaziz BA, El Kassas M, El Attar IH, Emadeldeen M, Abd-Elsalam SM. High success rates for the use of sofosbuvir/ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir/simeprevir/daclatasvir + ribavirin in retreatment of chronic hepatitis C infection after unsuccessful sofosbuvir/daclatasvir therapy: a real-life experience. Arch Virol. 2020 Jul;165(7):1633-1639. doi: 10.1007/s00705-020-04639-x. Epub 2020 Apr 30.'}, {'pmid': '29535545', 'type': 'DERIVED', 'citation': 'Ahmed OA, Kaisar HH, Badawi R, Hawash N, Samir H, Shabana SS, Fouad MHA, Rizk FH, Khodeir SA, Abd-Elsalam S. Efficacy and safety of sofosbuvir-ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection. Infect Drug Resist. 2018 Mar 1;11:295-298. doi: 10.2147/IDR.S153060. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration of Interferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects.', 'detailedDescription': 'Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration ofInterferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects. The introduction of direct acting antiviral agents, in particular sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • HCV infection\n\n * Adult patients, 18years and older.\n\nExclusion Criteria:\n\n* • Child score \\> 12\n\n * Severe Renal impairment\n * Pregnant and lactating women\n * HCC or other malignant neoplasms\n * Co-infection with human immunodeficiency virus (HIV)\n * Co-infection with hepatitis B virus (HBV)'}, 'identificationModule': {'nctId': 'NCT02992457', 'briefTitle': 'Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis', 'orgStudyIdInfo': {'id': 'Asem Elfert'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sof-Riba', 'description': 'Sofosbuvir ribavirin 6 months.', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Ribavirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sof- Riba- Pegylated interferon', 'description': 'Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Ribavirin', 'Drug: Pegylated-interferon alfa-2a']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sof- Olysio', 'description': 'Sofosbuvir and simeprevir for 3 months.', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Simeprevir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sof- Dacla', 'description': 'Sofosbuvir and Daclatasvir for 3 months.', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Daclatasvir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Harvony', 'description': 'Sofosbuvir and ledipasvir for 3 months', 'interventionNames': ['Drug: Sofosbuvir and Ledipasvir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ritaprevir, paritaprevir, ombetasvir', 'description': 'Querevo for 3 months', 'interventionNames': ['Drug: Ritaprevir, paritaprevir, ombetasvir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salvage therapy', 'description': 'sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo', 'interventionNames': ['Drug: Salvage therapy']}], 'interventions': [{'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['sovaldi , mpiviropack'], 'description': 'Sofosbuvir 400 mg daily.', 'armGroupLabels': ['Sof- Dacla', 'Sof- Olysio', 'Sof- Riba- Pegylated interferon', 'Sof-Riba']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Rebetol, Riba'], 'description': 'Ribavirin 1000-1200 mg daily', 'armGroupLabels': ['Sof- Riba- Pegylated interferon', 'Sof-Riba']}, {'name': 'Pegylated-interferon alfa-2a', 'type': 'DRUG', 'otherNames': ['peginteron, pegasys'], 'description': 'Pegylated interferon alfa-2a once weekly for 3 months', 'armGroupLabels': ['Sof- Riba- Pegylated interferon']}, {'name': 'Simeprevir', 'type': 'DRUG', 'otherNames': ['Olysio'], 'description': 'Olysio once daily.', 'armGroupLabels': ['Sof- Olysio']}, {'name': 'Daclatasvir', 'type': 'DRUG', 'otherNames': ['Daklatasvir, Dakla'], 'description': 'Dakla once daily for three months.', 'armGroupLabels': ['Sof- Dacla']}, {'name': 'Ritaprevir, paritaprevir, ombetasvir', 'type': 'DRUG', 'otherNames': ['querevo'], 'description': 'Querevo for three months', 'armGroupLabels': ['Ritaprevir, paritaprevir, ombetasvir']}, {'name': 'Sofosbuvir and Ledipasvir', 'type': 'DRUG', 'otherNames': ['Harvony'], 'description': 'Once daily for three months', 'armGroupLabels': ['Harvony']}, {'name': 'Salvage therapy', 'type': 'DRUG', 'otherNames': ['Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo'], 'description': 'three months in repeated treatment failure', 'armGroupLabels': ['Salvage therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta university hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Asem Elfert, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta university hospital'}, {'name': 'Lobna Abo ALi, Ass Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta university hospital'}, {'name': 'Sabry Abou Saif, Ass Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta university hospital'}, {'name': 'Taher Eldemerdash, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University hospital'}, {'name': 'Hala M Elsabagh, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University hospital'}, {'name': 'Mohamed Elkassas, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Helwan University'}, {'name': 'Eslam Esmail, Ass Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Tanta University'}, {'name': 'Sherief Abd-Elsalam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}