Overview

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