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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?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01151397
First received: June 16, 2010
Last updated: April 27, 2011
Last verified: June 2010
History of Changes
  Purpose

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 Intervention
Chronic Hepatitis C
 Drug: Peg + Vitamin D + Ribavirin
Drug: Peg + Ribavirin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • sustained virologic response (SVR)rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    the SVR rate data will be collected and compared for 2 groups


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01151397     History of Changes
Other Study ID Numbers: Genotype 2,3 HCV +Vitamin D
Study First Received: June 16, 2010
Last Updated: April 27, 2011
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 21, 2013