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

NCT01151397 | Unknown

• 1 other identifier: Genotype 2,3 HCV +Vitamin D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 2.whether Vitamin D levels predicts negative treatment outcome.

Conditions

Chronic Hepatitis C

Keywords

SVR; VITAMIN D; Hepatitis C; Genotype 2,3; Naive; RVR

Outcome Measures

Primary Outcomes (1)

• sustained virologic response (SVR)rate

  the SVR rate data will be collected and compared for 2 groups

  24 weeks

Study Arms (2)

Peg + Vitamin D + Ribavirin

ACTIVE COMPARATOR

Peg + Vitamin D + Ribavirin for 3 months

Drug: Peg + Vitamin D + Ribavirin

Peg + Ribavirin

ACTIVE COMPARATOR

Peg + Ribavirin for 6 months

Drug: Peg + Ribavirin

Interventions

Peg + Vitamin D + Ribavirin DRUG

Peg+ Vitamin D+ Ribavirin for 3 months

Peg + Vitamin D + Ribavirin

Peg + Ribavirin DRUG

Peg+ Ribavirin for 6 months

Peg + Ribavirin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Ziv medical center liver unit

Safed, Israel, 13100, Israel

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Polyethylene Glycols; Vitamin D; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Assy Nimer

CONTACT

+97246828445; assy.n@ziv.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 28, 2010
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 28, 2011

Record last verified: 2010-06

Locations

IL (1)