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

Chronic Hepatitis C research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Hepatitis C

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Peg + Vitamin D + RibavirinPeg+ Vitamin D+ Ribavirin for 3 months

Drug:Peg + RibavirinPeg+ Ribavirin for 6 months

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Peg + Vitamin D + RibavirinPeg + Vitamin D + Ribavirin for 3 months

Peg + RibavirinPeg + Ribavirin for 6 months

Study Status

Unknown status

Start Date: August 2011

Completed Date: July 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: sustained virologic response (SVR)rate

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Ziv Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01151397

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