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
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
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
Start Date: August 2011
Completed Date: July 2012
Primary Outcome: sustained virologic response (SVR)rate
Study sponsors, principal investigator, and references
Lead Sponsor: Ziv Hospital