Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-06-25 @ 1:43 AM
Study NCT ID:
NCT02771405
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2016-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'D000069616', 'term': 'Simeprevir'}, {'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'C586541', 'term': 'ledipasvir'}, {'id': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2016-05-06', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment', 'timeFrame': '12 weeks after the last dose of study drugs'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with virologic failure during treatment or relapse after treatment', 'timeFrame': 'from baseline until 12 weeks after the last dose of study drugs'}, {'measure': 'Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC', 'timeFrame': 'Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HCV-HCC-DAAs'], 'conditions': ['Hepatitis C, Chronic', 'Hepatocellular Carcinoma']}, 'referencesModule': {'availIpds': [{'url': 'http://www.megafileupload.com/f3sT/Attachments_201656.zip', 'type': 'Informed Consent Form'}], 'references': [{'pmid': '29727383', 'type': 'DERIVED', 'citation': 'Hassany M, Elsharkawy A, Maged A, Mehrez M, Asem N, Gomaa A, Mostafa Z, Abbas B, Soliman M, Esmat G. Hepatitis C virus treatment by direct-acting antivirals in successfully treated hepatocellular carcinoma and possible mutual impact. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):876-881. doi: 10.1097/MEG.0000000000001152.'}]}, 'descriptionModule': {'briefSummary': 'The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.', 'detailedDescription': 'The study will recruit 150 patients with HCV related HCC All the studied patients underwent or will undergo one of the curative interventions for HCC either hepatic resection or thermal ablation .\n\nafter 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens :\n\n1. Sofosbuvir+Ribavirin\n2. Sofosbuvir+Simeprevir± Ribavirin\n3. Sofosbuvir+ Daclatasvir ± Ribavirin\n4. Sofosbuvir+ Ledipasvir ± Ribavirin\n\nthe treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years old\n* Confirmed HCV viremia by PCR\n* CHILD Pugh "A" or "B7,B8"\n* Confirmed HCC either by laboratory ,imaging or histopathological criteria\n* Underwent or candidate for curative intervention for HCC (BCLC stage 0 ,A)\n* Willing to be treated for HCV and signing informed consent\n\nExclusion Criteria:\n\n* Patients below 18 or above 70 years old\n* patients with advanced liver condition "CHILD score ≥ B9"\n* Patients with advanced HCC status (BCLC≥ B)\n* Patients with combined HBV ,HIV infection'}, 'identificationModule': {'nctId': 'NCT02771405', 'acronym': 'FRI-STC', 'briefTitle': 'Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Hepatology & Tropical Medicine Research Institute'}, 'officialTitle': 'Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC', 'orgStudyIdInfo': {'id': '4/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir +Ribavirin', 'description': 'Sofosbuvir 400 mg/day +ribavirin for 24 weeks', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir+Simeprevir±Ribavirin', 'description': 'Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Ribavirin', 'Drug: Simeprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir+Daclatasvir±Ribavirin', 'description': 'Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Ribavirin', 'Drug: daclatasvir']}, {'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir+Ledipasvir±Ribavirin', 'description': 'Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks', 'interventionNames': ['Drug: Sofosbuvir', 'Drug: Ribavirin', 'Drug: Ledipasvir']}], 'interventions': [{'name': 'Sofosbuvir', 'type': 'DRUG', 'otherNames': ['Sovaldi®', 'GS-7977'], 'description': 'Sofosbuvir 400 mg orally once daily', 'armGroupLabels': ['Sofosbuvir +Ribavirin', 'Sofosbuvir+Daclatasvir±Ribavirin', 'Sofosbuvir+Ledipasvir±Ribavirin', 'Sofosbuvir+Simeprevir±Ribavirin']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus®', 'Rebetol®'], 'description': 'Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)', 'armGroupLabels': ['Sofosbuvir +Ribavirin', 'Sofosbuvir+Daclatasvir±Ribavirin', 'Sofosbuvir+Ledipasvir±Ribavirin', 'Sofosbuvir+Simeprevir±Ribavirin']}, {'name': 'Simeprevir', 'type': 'DRUG', 'otherNames': ['Olysio®', 'TMC435'], 'description': 'Simeprevir 150 mg orally once daily', 'armGroupLabels': ['Sofosbuvir+Simeprevir±Ribavirin']}, {'name': 'daclatasvir', 'type': 'DRUG', 'otherNames': ['clatazev®', 'BMS-790052'], 'description': 'Daclatasvir 60 mg orally once daily', 'armGroupLabels': ['Sofosbuvir+Daclatasvir±Ribavirin']}, {'name': 'Ledipasvir', 'type': 'DRUG', 'otherNames': ['Co-formulated with Sofosbuvir in one tablet (Harvoni ® )'], 'description': 'Ledipasvir 90 mg orally once daily', 'armGroupLabels': ['Sofosbuvir+Ledipasvir±Ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11441', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Amr Maged', 'role': 'CONTACT', 'email': 'amrrasheed88@gmail.com'}], 'facility': 'Amr Maged', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Hassany, MD.', 'role': 'CONTACT', 'email': 'mohamadhassany@yahoo.com', 'phone': '+2 01128500015'}, {'name': 'Aisha El Sharkawy, MD', 'role': 'CONTACT', 'email': 'a_m_sharkawy@yahoo.com', 'phone': '+2 01222211004'}], 'overallOfficials': [{'name': 'Gamal Esmat, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Aisha El Sharkawy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Mohamed Hassany, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Hepatology & Tropical Medicine Research Institute (NHTMRI)'}, {'name': 'Mai Mehrez, MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Hepatology & Tropical Medicine Research Institute (NHTMRI)'}, {'name': 'Amr Maged', 'role': 'STUDY_CHAIR', 'affiliation': 'National Hepatology & Tropical Medicine Research Institute (NHTMRI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Hepatology & Tropical Medicine Research Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hepatology & Gastroenterology Consultant , Director of HCC Unit', 'investigatorFullName': 'Mohamed Hassany', 'investigatorAffiliation': 'National Hepatology & Tropical Medicine Research Institute'}}}}