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

April 27, 2011 updated by: Ziv Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Safed, Israel, Israel, 13100
        • Ziv medical center liver unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peg + Vitamin D + Ribavirin
Peg + Vitamin D + Ribavirin for 3 months
Drug: Peg + Vitamin D + Ribavirin
Peg+ Vitamin D+ Ribavirin for 3 months
Active Comparator: Peg + Ribavirin
Peg + Ribavirin for 6 months
Drug: Peg + Ribavirin
Peg+ Ribavirin for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sustained virologic response (SVR)rate
Time Frame: 24 weeks
the SVR rate data will be collected and compared for 2 groups
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Genotype 2,3 HCV +Vitamin D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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