Hepatitis C Clinical Trial
Official title:
Randomized Clinical Trial to Assess the Effectiveness of Vitamin D and Vitamin B12 Supplementation in Combination With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C.
Verified date | August 2016 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 85 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Outpatient Clinic of Viral Hepatitis (NUPAIG) | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SVR12 | Proportion of patients with SVR, defined as HCV RNA bellow the limit of detection 12 weeks after treatment completion with peguilated alfainterferon-2B plus ribavirin, with or without vitamin supplementation. | 12 weeks after treatment completion | No |
Secondary | RVR, EVR, EOT | Proportion of patients presenting HCV RNA bellow the limit of detection at week 4 (RVR), week 12 (EVR - early virological response) and at the end-of-treatment (EOT); | week 4, week 12 and at the end-of-treatment. | No |
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