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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
Pharmacologic Actions
Bone Density Conservation Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014