Back to resultsDoes 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?
Primary Purpose
Chronic Hepatitis C
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Peg + Vitamin D + Ribavirin
Peg + Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring SVR, VITAMIN D, Hepatitis C, Genotype 2,3, Naive, RVR
Eligibility Criteria
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
Sites / Locations
- Ziv medical center liver unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Peg + Vitamin D + Ribavirin
Peg + Ribavirin
Arm Description
Peg + Vitamin D + Ribavirin for 3 months
Peg + Ribavirin for 6 months
Outcomes
Primary Outcome Measures
sustained virologic response (SVR)rate
the SVR rate data will be collected and compared for 2 groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151397
Brief Title
Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?
Official Title
Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ziv Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
SVR, VITAMIN D, Hepatitis C, Genotype 2,3, Naive, RVR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peg + Vitamin D + Ribavirin
Arm Type
Active Comparator
Arm Description
Peg + Vitamin D + Ribavirin for 3 months
Arm Title
Peg + Ribavirin
Arm Type
Active Comparator
Arm Description
Peg + Ribavirin for 6 months
Intervention Type
Drug
Intervention Name(s)
Peg + Vitamin D + Ribavirin
Intervention Description
Peg+ Vitamin D+ Ribavirin for 3 months
Intervention Type
Drug
Intervention Name(s)
Peg + Ribavirin
Intervention Description
Peg+ Ribavirin for 6 months
Primary Outcome Measure Information:
Title
sustained virologic response (SVR)rate
Description
the SVR rate data will be collected and compared for 2 groups
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Assy Nimer
Phone
+97246828445
Email
assy.n@ziv.health.gov.il
Facility Information:
Facility Name
Ziv medical center liver unit
City
Safed, Israel
ZIP/Postal Code
13100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimer Assy
Phone
+972-46828445
Email
assy.n@ziv.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?
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