Back to resultsDoes Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?
Primary Purpose
Hepatitis C
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Peg+ Vitamin D+ Ribavirine
Peg+ Ribavirine
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Vitamin D, Hepatitis C, Genotype2,3, SVR, Naive, RVR rate, EVR rate, SVR rate
Eligibility Criteria
Inclusion Criteria:
- 18 to 65 years of age,
- Chronic genotype 2,3 HCV infection, Traetment 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
- Arythmia
- Active CAD
- Positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease
Sites / Locations
- Liver clinic
- Ziv medical center liver unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Peg+ Vitamin D+ Ribavirine
Peg+ Ribavirine
Arm Description
Peg+ Vitamin D+ Ribavirine
Peg+ Ribavirine
Outcomes
Primary Outcome Measures
SVR rate
to evaluate the response rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01146626
First Posted
June 16, 2010
Last Updated
April 27, 2011
Sponsor
Ziv Hospital
Collaborators
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01146626
Brief Title
Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?
Official Title
Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin
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
May 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ziv Hospital
Collaborators
Hillel Yaffe Medical Center
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
whether adding vitamin D, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
whether Vitamin D levels predictes 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, could improve viral respons.The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 2,3 patients with chronic HCV infection 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
Hepatitis C
Keywords
Vitamin D, Hepatitis C, Genotype2,3, SVR, Naive, RVR rate, EVR rate, SVR rate
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+ Ribavirine
Arm Type
Active Comparator
Arm Description
Peg+ Vitamin D+ Ribavirine
Arm Title
Peg+ Ribavirine
Arm Type
Experimental
Arm Description
Peg+ Ribavirine
Intervention Type
Drug
Intervention Name(s)
Peg+ Vitamin D+ Ribavirine
Intervention Description
Peg+ Vitamin D+ Ribavirine
Intervention Type
Drug
Intervention Name(s)
Peg+ Ribavirine
Intervention Description
Peg+ Ribavirine
Primary Outcome Measure Information:
Title
SVR rate
Description
to evaluate the response rate
Time Frame
1 year
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, Traetment 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
Arythmia
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, MD
Phone
+97246828445
Email
assy.n@ziv.health.gov.il
Facility Information:
Facility Name
Liver clinic
City
Hedera
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saif Abu Much, MD
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, MD
Phone
+972-46828445
Email
assy.n@ziv.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?
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