Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Treatments: Ergocalciferols; Hydroxocobalamin; Interferon-alpha; Interferons; Ribavirin; Vitamin B 12; Vitamin B Complex; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR

• Pegylated Interferon-Alfa treatment naïve

• Liver biopsy with Metavir F2 or less

• Cognitive capacity to understand and sign the informed consent

Exclusion Criteria:

• HBV or HIV co-infection

• Hemoglobin level less than 10 g/dL or total neutrophil count less than 1,500/mm3 or platlet count below 75,000/mm3

• Creatinin ≥ 1.5 mg/dL

• Severe cardiopathy

• Pregnancy or impossibility to use birth control methods by the couple, or breast-feeding

• Conditions that, according to the investigator's judgement, preclude participation in the study, including clinical, cognitive or behavioural conditions