Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c
This trial is active, not recruiting.
|Condition||chronic hepatitis c|
|Treatments||vitamin d +pegylated interferon + ribavirin, pegylated interferon + ribavirin|
|Start date||May 2012|
|End date||February 2014|
|Trial size||80 participants|
|Trial identifier||NCT01655966, RAIL002|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Sustained virologic response
time frame: 72 weeks
rapid virologic response
time frame: 4 weeks
time frame: 48 weeks
time frame: 72 weeks
early virologic response
time frame: 12 weeks
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - Adult (male or female), 18 to 65 years of age, with chronic HCV infection - Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system - 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) - 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 - Patients must be serum hepatitis B surface antigen (HBsAg) negative - Negative Antinuclear Antibodies (ANA) or titer of < 1:160 - Serum positive for anti-HCV antibodies and HCV-RNA - Abdominal Ultrasound obtained within 3 months prior to entry in the study - Electrocardiogram for men aged > 40 years and for women aged > 50 years - Normal fundus examination - Proper contraception measure throughout the course of treatment and six months later - Female patients must not breast feed during therapy Exclusion Criteria: - Patients who previously received interferon - HgbA1c > 7.5 or history of diabetes mellitus - BMI > 34 - Women who are pregnant or breast-feeding - Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active - Other causes of liver disease including autoimmune hepatitis - Transplant recipients receiving immune suppression therapy - Screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab - Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score > 6 or MELD score > 8 - 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 - Hypothyroidism or hyperthyroidism not effectively treated with medication - Alcohol consumption of > 40 grams per day or an alcohol use pattern that will interfere with the study - History or other clinical evidence of significant or unstable cardiac disease - History or other clinical evidence of chronic pulmonary disease associated with functional impairment - Serious or severe bacterial infection(s) - History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization - History of uncontrolled severe seizure disorder - History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids - Patients with clinically significant retinal abnormalities - Subjects receiving vitamin D for any other medical condition. - Subjects with significant active rheumatologic or orthopaedic conditions.
|Official title||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.|
|Principal investigator||Tamer Elbaz, MD|
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