Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-05 @ 5:43 PM
Study NCT ID:
NCT01655966
Status:
UNKNOWN
Last Update Posted:
2014-01-29
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virologic response', 'timeFrame': '72 weeks', 'description': 'Undetectable HCV-RNA 24 weeks after end of treatment.'}], 'secondaryOutcomes': [{'measure': 'rapid virologic response', 'timeFrame': '4 weeks', 'description': 'undetectable HCV-RNA 4 weeks after commencement of treatment'}, {'measure': 'End-of-treatment response', 'timeFrame': '48 weeks', 'description': 'undetectable HCV-RNA 48 weeks after commencement of treatment'}, {'measure': 'Adverse events', 'timeFrame': '72 weeks', 'description': 'Adverse events that could be reasonably and temporally associated with administration of drugs'}, {'measure': 'early virologic response', 'timeFrame': '12 weeks', 'description': 'Early virologic response: undetectable HCV-RNA 12 weeks after commencement of treatment.\n\nPartial early virologic response: decrease of more than 2login HCV-RNA.\n\nNo early virologic response: increase, stationary or decreased less than 2log HCV-RNA.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic hepatitis c', 'hcv', 'vitamin d'], 'conditions': ['Chronic Hepatitis c']}, 'descriptionModule': {'briefSummary': 'Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4. Conventional standard of care treatment has modest response with only 50% sustained virologic response. Recent reports have suggested an augmented response with the addition of vitamin D. This is a prospective randomized trial to assess the effectiveness of adding vitamin D to standard of care for chronic hepatitis C genotype 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (male or female), 18 to 65 years of age, with chronic HCV infection\n* Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system\n* Compensated liver disease; serum bilirubin \\< 1.5 mg/dl, INR no more than 1.5, serum albumin \\> 3.4, platelet count \\> 75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites)\n* Acceptable hematological and biochemical indices (hemoglobin 12.5g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine \\< 1.5 mg/dl\n* Patients must be serum hepatitis B surface antigen (HBsAg) negative\n* Negative Antinuclear Antibodies (ANA) or titer of \\< 1:160\n* Serum positive for anti-HCV antibodies and HCV-RNA\n* Abdominal Ultrasound obtained within 3 months prior to entry in the study\n* Electrocardiogram for men aged \\> 40 years and for women aged \\> 50 years\n* Normal fundus examination\n* Proper contraception measure throughout the course of treatment and six months later\n* Female patients must not breast feed during therapy\n\nExclusion Criteria:\n\n* Patients who previously received interferon\n* HgbA1c \\> 7.5 or history of diabetes mellitus\n* BMI \\> 34\n* Women who are pregnant or breast-feeding\n* Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active\n* Other causes of liver disease including autoimmune hepatitis\n* Transplant recipients receiving immune suppression therapy\n* Screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab\n* Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score \\> 6 or MELD score \\> 8\n* Absolute neutrophil count \\< 1500 cells/mm3; platelet count \\< 135,000 cells/mm3; hemoglobin \\< 12 g/dL for women and \\< 12.5 g/dL for men; or serum creatinine concentration ≥ 1.5 times ULN\n* Hypothyroidism or hyperthyroidism not effectively treated with medication\n* Alcohol consumption of \\> 40 grams per day or an alcohol use pattern that will interfere with the study\n* History or other clinical evidence of significant or unstable cardiac disease\n* History or other clinical evidence of chronic pulmonary disease associated with functional impairment\n* Serious or severe bacterial infection(s)\n* History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization\n* History of uncontrolled severe seizure disorder\n* History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids\n* Patients with clinically significant retinal abnormalities\n\n * Subjects receiving vitamin D for any other medical condition.\n * Subjects with significant active rheumatologic or orthopaedic conditions.'}, 'identificationModule': {'nctId': 'NCT01655966', 'briefTitle': 'Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Vitamin D in Addition to Pegylated Interferon and Ribavirin Compared to Pegylated Interferon and Ribavirin Alone in the Treatment of Chronic Hepatitis C Genotype 4.', 'orgStudyIdInfo': {'id': 'RAIL002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Group A: comprises 40 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \\< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.', 'interventionNames': ['Drug: pegylated interferon + ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Triple therapy', 'description': 'Group B: comprises 40 treatment-naive chronic HCV patients who will receive oral vitamin D 1mcg once daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \\< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.', 'interventionNames': ['Drug: vitamin D +pegylated interferon + ribavirin']}], 'interventions': [{'name': 'vitamin D +pegylated interferon + ribavirin', 'type': 'DRUG', 'description': 'Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(\\> 75kg:1200 mg, \\<75kg:1000mg daily)48 weeks', 'armGroupLabels': ['Triple therapy']}, {'name': 'pegylated interferon + ribavirin', 'type': 'DRUG', 'description': 'pegylated interferon 160ug once weekly Ribavirin (\\> 75kg:1200 mg, \\<75kg:1000mg daily)48 weeks', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Railway Hospital Center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Tamer Elbaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Hany Shehab, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Hany Shehab', 'investigatorAffiliation': 'Cairo University'}}}}