Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-04 @ 5:18 AM
Study NCT ID:
NCT04122066
Status:
UNKNOWN
Last Update Posted:
2020-03-30
First Post:
2019-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Pulmonary Safety of Antihepatitis C Treatment
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-26', 'studyFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the pulmonary side effect of the new anti HCV medication in our population.', 'timeFrame': '3 months', 'description': 'find out the pulmonary side effects of the new anti hepatitis C treatment (sovosbuvir based regimen )'}], 'secondaryOutcomes': [{'measure': 'the factors that increase the incidence of pulmonary complications', 'timeFrame': '3 months', 'description': 'Identification the factors that increase the incidence of pulmonary complications with the new anti HCV medications'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'pulmonary side effects of the new regimen of antihepatitis C', 'detailedDescription': 'Hepatitis C is a liver disease caused by the hepatitis C virus.The hepatitis C virus is a blood borne virus The most common modes of infection are through exposure to small quantities of blood, through injection drug use, unsafe injection practices, unsafe health care, and the transfusion of unscreened blood and blood products.\n\nAn estimated 71 million people have chronic hepatitis C infection. A significant number of those who are chronically infected will develop cirrhosis and or liver cancer. the treatment of hepatitis C virus (HCV) infection has been difficult, particularly in patients with HCV genotype 1. Reasons for the difficulty include the inherent toxicity and limited efficacy of interferon-based therapy, which has been the cornerstone of anti-HCV efforts during the past 2 decades.\n\nNewly available direct-acting antiviral agents (DAAs) have the potential to dramatically improve HCV eradication rates. Despite these new drugs has been characterized by a very low adverse events rate in the published clinical trials Few data are available on pulmonary adverse events based real life studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 patients diagnosed as HCV positive and eligible for search criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. HCV RNA positivity .\n\nExclusion Criteria:\n\n* Child C cirrhosis.\n* Clinically manifest liver decompensation :ascites ,encephalopathy, wasting, hepatorenal syndrome.\n* Serum albumin less than 2.8 g/dl,total serum bilirubin more than 3 mg/dl ,INR1.7 or more .\n* absolute neutrophil counts \\< 1500\\\\mm3 and\\\\or platelet less than 50,000/mm3.\n* HCC except 6 months after concluding intervention aiming at cure with no evidence of activity by dynamic CT or MRI.\n* Extrahepatic malignancy except after two years of disease\\\\disease free interval\n* In lymphomas and chronic lymphatic leukemia can be initiated immediately after remission based on the treating oncologist's report\n* Pregnancy or inability to use effective contraception\n* Inadequately controlled diabetes mellitus (HbA1c\\>9%)\n* sever renal impairment in which creatinine clearance \\< 30 ml\\\\min\n* chronic lung diseases ."}, 'identificationModule': {'nctId': 'NCT04122066', 'briefTitle': 'the Pulmonary Safety of Antihepatitis C Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Pulmonary Safety of the New Oral Antihepatitis C Treatment', 'orgStudyIdInfo': {'id': 'safety of antihepatiis C drugs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'respiratory symptoms reported in studied patients', 'description': 'If Sofosbuvir\\\\Daclatasvir regimen has respiratory side effects or not and the factors increase incidence of respiratory complications', 'interventionNames': ['Drug: sofosbuvir \\daclatsvir']}], 'interventions': [{'name': 'sofosbuvir \\daclatsvir', 'type': 'DRUG', 'otherNames': ['Sovaldi\\Daklinza'], 'description': 'study the effect of the new oral antihepatitis C drugs on the respiratory system', 'armGroupLabels': ['respiratory symptoms reported in studied patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marina Saman', 'role': 'CONTACT', 'email': 'marina011335@med.au.edu.eg', 'phone': '01204171412'}], 'overallOfficials': [{'name': 'Safaa Mokhtar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Nahed Makhlouf', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Mostafa kamal', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Marina Omil Saman', 'investigatorAffiliation': 'Assiut University'}}}}