Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 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 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks) whether Vitamin D levels predicts negative treatment outcome.

Detailed Description
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Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2, 3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, for 3 months therapy could improve viral response. The working hypothesis is that 3 months therapy with Vitamin D + Peg + Ribavirin significantly improves RVR, EVR, and SVR.

Official Title
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Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients?

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peg + Vitamin D + Ribavirin
* Drug: Peg + Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 65 years of age chronic genotype 2,3 HCV infection treatment Naive negative sero for HBV, HDV and HIV viral infections absolute neutrophil count of >1500 per cubic millimeter a platelet count of >90,000 per cubic millimeter normal hemoglobin level Exclusion Criteria: decompensated liver disease (cirrhosis with CP score >9) another cause of clinically significant liver disease hepato cellular carcinoma psychiatric Disorder chronic heart failure pregnant women uncontrolled diabetes with retinopathy Arrhythmia Active CAD positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peg + Vitamin D + Ribavirin<br>Peg + Vitamin D + Ribavirin for 3 months | Drug: Peg + Vitamin D + Ribavirin<br>* Peg+ Vitamin D+ Ribavirin for 3 months<br>|
| Active Comparator: Peg + Ribavirin<br>Peg + Ribavirin for 6 months | Drug: Peg + Ribavirin<br>* Peg+ Ribavirin for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained virologic response (SVR)rate | the SVR rate data will be collected and compared for 2 groups | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SVR, VITAMIN D, Hepatitis C, Genotype 2,3, Naive, RVR