Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Ergocalciferols; Interferons; Peginterferon alfa-2a; Ribavirin; Vitamin D; Vitamins

Criteria

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.