Efficacy and Safety of the Combination Vitamin D With Standard of Care in Egyptian Patients With Untreated Chronic Hepatitis C

• Status: Withdrawn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

Summary

The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with standard PEG-IFN + RBV in untreated Egyptian patients with chronic hepatitis C, on the sustained virological response (SVR) at 3 months after end of treatment (week 60).

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

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Institut Pasteur
• Treatments: Ergocalciferols; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

Common with National Program for Viral Hepatitis

• Age: 18 years to 60 years

• Positive HCV antibodies using a third generation test

• Detectable HCV RNA by PCR

• Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3

• Naïve to treatment with PEG-IFN and RBV

• HBs antigen negative

• Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein < 3*normal range of the laboratory, anti-nuclear antibodies<1/160 Effective contraception during the treatment period; no breast-feeding

Specific to the trial

• Prior approval from the Ministry of Health to be treated as part of the National Program with allocation to Peg-IFN α2b treatment

• Living <100 km from Cairo and able to come to the centre every week for the treatment

• Signed informed consent and willingness to participate in the trial

• Naïve to treatment with vitamin D (received vitamin D less than 30 consecutive days in the 3 months preceding inclusion)

• Biopsy slide validated by NHTMRI pathologist

Exclusion Criteria:

Common with National program for Viral Hepatitis

• Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C>8%) , chronic obstructive pulmonary disease

• Major uncontrolled depressive illness

• Solid transplant organ (renal, heart, or lung)

• Untreated thyroid disease

• History of previous anti-HCV therapy

• Body mass index (BMI) greater than 30 kg/m²

• Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial

• Anti-HCV therapy contraindications:

• hypersensitivity to one of the two drugs (PEG-IFN, RBV)

• pregnancy or unwilling to comply with adequate contraception

• breast-feeding

• neutropenia (<1500/mm3)

• anaemia (<11g/dL for women ; <12g/dL for men)

• thrombocytopenia (<100,000/mm3)

• elevated creatinin (>1.5mg/dL)

• concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease)

• liver biopsy showing severe steatosis (>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh>A); hepatocellular carcinoma, METAVIR score F4.

• TSH>5 mU/L

Specific to the trial

• Patients allocated to Peg-IFN alpha 2a treatment

• Hypersensitivity to vitamin D

• Vitamin D contraindications:

• hypercalcaemia (fasting calcaemia >105 mg/L or 2.62 mmol/L)

• ratio calciuria / creatininuria (fasting ratio >1 mmol Ca/mmol creatinin)

• hyperphosphatemia (>1.5 mmol/L)

• calcium lithiasis

• patients being treated with thiazide diuretics (risk of hypercalcaemia with vitamin D treatment)

• patients being treated with glucocorticoïds (decrease in vitamin D efficacy)

• postmenopausal women treated by vitamin D and calcium for osteoporosis

• Treatment by vitamin D more than 30 consecutive days in the 3 months preceding inclusion in the trial.