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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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ClinicalTrials.gov Identifier: NCT01151397
Recruitment Status : Unknown
Verified June 2010 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2010
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:
Ziv Hospital

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. 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Peg + Vitamin D + Ribavirin Drug: Peg + Ribavirin Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients?
Study Start Date : August 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. sustained virologic response (SVR)rate [ Time Frame: 24 weeks ]
    the SVR rate data will be collected and compared for 2 groups



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151397


Contacts
Contact: Assy Nimer +97246828445 assy.n@ziv.health.gov.il

Locations
Israel
Ziv medical center liver unit Not yet recruiting
Safed, Israel, Israel, 13100
Contact: Nimer Assy    +972-46828445    assy.n@ziv.health.gov.il   
Sponsors and Collaborators
Ziv Hospital

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01151397     History of Changes
Other Study ID Numbers: Genotype 2,3 HCV +Vitamin D
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: June 2010

Keywords provided by Ziv Hospital:
SVR
VITAMIN D
Hepatitis C
Genotype 2,3
Naive
RVR

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vitamins
Vitamin D
Ergocalciferols
Ribavirin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents