Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients

Study Overview
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Brief Summary
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Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.

Detailed Description
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The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.

Official Title
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A Randomized, Multi-center, Phase IV Open-label Study Evaluating the Antiviral Efficacy of Addition of Vitamin D in Patients With Treatment Naïve Chronic Hepatitis C Receiving Peginterferon Alfa-2a Plus Ribavirin

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Vit D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic genotype 1-3 HCV infection Treatment Naive Exclusion Criteria: Child B and C HCC patients Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Peginterferon alfa 2a+Ribavirin<br>standard of care for HCV : peginterferon alfa 2a and ribavirin | |
| Experimental: Vit D+Peginterferon alfa 2a+Ribavirin<br>VitD+Peginterferon alfa 2a+Ribavirin | Drug: Vit D<br>* 800IU/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Sustained virologic response (SVR) | Compare the number of participants with HCV RNA is not detected in the blood at 24 weeks post-treatment between vitamin D and control group. | 24w after completing Peg/RBV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with End of treatment response (ETR) | Compare the number of participants with HCV RNA is not detected in the blood at the end of treatment between two groups. HCV RNA pCR perform at 48 weeks in genotye 1, at 24 weeks in Genotye 2 and 3 | 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3 | 
| Number of participants with Rapid virological response (RVR) | Compare the number of participants with HCV RNA is notdetectable in the blood at week 4 of treatment between vitamin and control group | Week 4 | 
| Number of participants with Early virological response (EVR) | Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis C, SVR, Vit D, Peginterferon alfa 2a, Ribavirin