Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-02-27 @ 5:18 PM
Study NCT ID:
NCT03061032
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2017-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients
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': 'C586541', 'term': 'ledipasvir'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2017-02-17', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Virologic Response', 'timeFrame': '12 weeks after completion of treatment', 'description': 'Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic HCV infection\n* \\>18 years old\n\nExclusion Criteria:\n\n* HIV co-infected\n* Liver transplanted\n* Receiving drugs with suspected interactions'}, 'identificationModule': {'nctId': 'NCT03061032', 'acronym': 'HepCC-2', 'briefTitle': 'Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients', 'organization': {'class': 'OTHER', 'fullName': 'Iran Hepatitis Network'}, 'officialTitle': 'Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection', 'orgStudyIdInfo': {'id': 'IHN10002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir/Ledipasvir for 12W', 'description': 'Patients without cirrhosis and previous history of treatment will be treated with this regimen.\n\nDaily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.', 'interventionNames': ['Drug: Sofosbuvir/Ledipasvir 12W']}, {'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir/Ledipasvir+Ribavirin for 12W', 'description': 'Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen.\n\nDaily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.', 'interventionNames': ['Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12W']}, {'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir/Ledipasvir for 24W', 'description': 'Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen.\n\nDaily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.', 'interventionNames': ['Drug: Sofosbuvir/Ledipasvir 24W']}, {'type': 'EXPERIMENTAL', 'label': 'Sofosbuvir/Ledipasvir+Ribavirin for 24W', 'description': 'Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.', 'interventionNames': ['Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24W']}], 'interventions': [{'name': 'Sofosbuvir/Ledipasvir 12W', 'type': 'DRUG', 'description': 'Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.', 'armGroupLabels': ['Sofosbuvir/Ledipasvir for 12W']}, {'name': 'Sofosbuvir/Ledipasvir plus Ribavirin 12W', 'type': 'DRUG', 'description': 'Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.', 'armGroupLabels': ['Sofosbuvir/Ledipasvir+Ribavirin for 12W']}, {'name': 'Sofosbuvir/Ledipasvir 24W', 'type': 'DRUG', 'description': 'Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.', 'armGroupLabels': ['Sofosbuvir/Ledipasvir for 24W']}, {'name': 'Sofosbuvir/Ledipasvir plus Ribavirin 24W', 'type': 'DRUG', 'description': 'Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.', 'armGroupLabels': ['Sofosbuvir/Ledipasvir+Ribavirin for 24W']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Seyed Moayed Alavian, MD', 'role': 'CONTACT', 'email': 'alavian@thc.ir', 'phone': '+989121073195'}, {'name': 'Heidar Sharafi, PhD', 'role': 'CONTACT', 'email': 'h.sharafi@meldcenter.com', 'phone': '+989125176030'}], 'overallOfficials': [{'name': 'Seyed Moayed Alavian, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Iran Hepatitis Network'}, {'name': 'Heidar Sharafi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Iran Hepatitis Network'}, {'name': 'Bita Behnava, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iran Hepatitis Network'}, {'name': 'Mohammad Saeid Rezaee-Zavareh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iran Hepatitis Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iran Hepatitis Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baqiyatallah Research Center for Gastroenterology and Liver Diseases', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}