Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-07-31

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

1. Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
2. whether Vitamin D levels predicts negative treatment outcome.

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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.

Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peg + Vitamin D + Ribavirin

Peg + Vitamin D + Ribavirin for 3 months

Group Type ACTIVE_COMPARATOR

Peg + Vitamin D + Ribavirin

Intervention Type DRUG

Peg+ Vitamin D+ Ribavirin for 3 months

Peg + Ribavirin

Peg + Ribavirin for 6 months

Group Type ACTIVE_COMPARATOR

Peg + Ribavirin

Intervention Type DRUG

Peg+ Ribavirin for 6 months

Interventions

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Peg + Vitamin D + Ribavirin

Peg+ Vitamin D+ Ribavirin for 3 months

Intervention Type DRUG

Peg + Ribavirin

Peg+ Ribavirin for 6 months

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No