Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Treatments vitamin d +pegylated interferon + ribavirin, pegylated interferon + ribavirin
Phase phase 3
Sponsor Cairo University
Start date May 2012
End date February 2014
Trial size 80 participants
Trial identifier NCT01655966, RAIL002

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
pegylated interferon + ribavirin
pegylated interferon 160ug once weekly Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
(Experimental)
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.
vitamin d +pegylated interferon + ribavirin
Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(> 75kg:1200 mg, <75kg:1000mg daily)48 weeks

Primary Outcomes

Measure
Sustained virologic response
time frame: 72 weeks

Secondary Outcomes

Measure
rapid virologic response
time frame: 4 weeks
End-of-treatment response
time frame: 48 weeks
Adverse events
time frame: 72 weeks
early virologic response
time frame: 12 weeks

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Cairo University.