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

Not Applicable

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Peg + Ribavirin; Drug: Peg + Vitamin D + Ribavirin

• Registration Number: NCT01151397
• Lead Sponsor: Ziv Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-28
• Study Start: 2011-08
• Primary Completion: 2012-02
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peg + Ribavirin	Peg + Ribavirin	Peg + Ribavirin for 6 months
Peg + Vitamin D + Ribavirin	Peg + Vitamin D + Ribavirin	Peg + Vitamin D + Ribavirin for 3 months

Primary Outcome Measures

Name	Time	Method
sustained virologic response (SVR)rate	24 weeks	the SVR rate data will be collected and compared for 2 groups

Trial Locations

Locations (1)

Ziv medical center liver unit; 🇮🇱 Safed, Israel, Israel