Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?
Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin
1 other identifier
interventional
60
1 country
2
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.whether adding vitamin D, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
- 2.whether Vitamin D levels predictes negative treatment outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedApril 28, 2011
June 1, 2010
6 months
June 16, 2010
April 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SVR rate
to evaluate the response rate
1 year
Study Arms (2)
Peg+ Vitamin D+ Ribavirine
ACTIVE COMPARATORPeg+ Vitamin D+ Ribavirine
Peg+ Ribavirine
EXPERIMENTALPeg+ Ribavirine
Interventions
Eligibility Criteria
You may qualify if:
- 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
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
- Arythmia
- Active CAD
- Positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ziv Hospitallead
- Hillel Yaffe Medical Centercollaborator
Study Sites (2)
Liver clinic
Hedera, Israel
Ziv medical center liver unit
Safed, Israel, 13100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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 17, 2010
Study Start
August 1, 2011
Primary Completion
February 1, 2012
Study Completion
May 1, 2012
Last Updated
April 28, 2011
Record last verified: 2010-06